DESC:
TECHNICAL FIELD OF INVENTION
[001] The present invention relates to the field of management of cardiovascular diseases in patients. In particular, with the digital health intervention and remote patient monitoring.

BACKGROUND OF THE INVENTION
[002] Cardiovascular diseases (CVD) are the leading cause of death globally. According to the WHO, the global prevalence of CVD was estimated to be approximately 470 million and Globally, around 17.9 million people annually die due to CVDs. More than four out of five CVD deaths are due to heart attacks and strokes, and one third of these deaths occur prematurely in people under 70 years of age. The number of people with total CVD nearly doubled from 271 million in 1990 to 523 million in 2019, and deaths due to CVD climbed significantly from 12.1 million in 1990 to 18.6 million in 2019.

[003] The term CVD encompasses a wide range of diseases, including ischemic heart disease, cerebrovascular disease, hypertensive heart disease, peripheral vascular disease, rheumatic heart disease, cardiomyopathies and arrhythmias, among others. The majority of CVD is related to a combination of behavioral and metabolic risk factors. Important modifiable behavioral risk factors include smoking, physical inactivity and unhealthy diet. The long-term presence of behavioral risk factors can lead to the metabolic risk factors, such as hypertension, diabetes, dyslipidemia an overweight/obesity.

[004] The cornerstone of CVD management and prevention is based on interventions to motivate lifestyle modification and adherence to effective cardiovascular medications. Successful strategies to promote smoking cessation, increase physical activity levels, motivate healthy diet and improve medication adherence are associated with improvements in morbidity and reductions in mortality. However, given the millions of people at risk for or with CVD, there are practical, logistical, geographical and financial challenges associated with delivering comprehensive risk factor management to diverse populations. Health systems throughout the world are charged with finding ways to reach more people in efficient and scalable ways.

[005] Major advances in internet and mobile technology over the past decade provide potential solutions to reduce the burden of CVD and broaden the reach of health care. According to Deloitte's 2022 Global TMT (Technology, Media and Entertainment, Telecom) predictions, the smartphone market is expected to reach 1 billion smartphone users by 2026. The widespread use of smart mobile devices has significantly affected the number of patients using healthcare systems. The number of patients using mobile devices in India has increased from 35,000 in 2013 to 7 million in 2018 and opportunities to deliver healthcare digitally are expanding exponentially. Developing e-health systems (e.g., remote patient monitoring (RPM), electronic health record (EHR) systems, mobile health (m-health), telemedicine, e-visits, e-consultations, etc.) is an increasing need. Such systems are used for continuous monitoring, diagnosis, prediction, and treatment. Consequently, they contribute to reducing healthcare costs and allow patients to perform their daily activities while their vital signs are fully monitored. Besides, these systems allow physicians to follow up with patients at any time, not just when patients are physically present at a hospital. Patient monitoring (PM) systems work to empower patients with knowledge about their symptoms and treatments, helping them live independently which helps to increase their quality of life. On the other hand, PM systems are important in hospitals; for example, they can be used to rank patients based on their conditions, allowing hospitals to prioritize critical patient care.

[006] Most mobile health apps, health software applications or health related websites, despite their increasing popularity among both consumers and health professionals, lack evidence and are developed without involvement of medical professionals, caregiver, dietician, fitness expert and personalized health assistant and thereby potentially compromising safety. Moreover, since older people may need assistance to use many smartphone features, instruction and support is critical. Further, the mobile application should be user friendly and should be easily operable.

[007] Ensuring adherence to prescribed medication is crucial for effective medical treatment and deriving maximum benefits from it. Patients need to take the recommended medication to manage their condition successfully. A retrospective study has demonstrated that individuals with Acute coronary syndrome (ACS) who maintained a medication adherence rate of at least 90% were less likely to experience MACE than those with an adherence rate of less than 90%.

[008] The adherence to secondary prevention medication after ACS is not up to desired level worldwide. Studies show that low adherence and persistence rates are common among the stroke patients. Post-ACS discharge, reported rate of unplanned readmissions due to cardiovascular issues is 21.4%, and the rate of non-adherence to medication is 37.97%. The adherence rate to post percutaneous coronary intervention (Post-PCI) medications among patients with ST-segment elevation myocardial infarction (STEMI) is also relatively low (28.4%). Indians are more susceptible to frequent hospitalizations due to complications of Coronary artery disease (CAD), with admission rates being much higher for populations under 40 years old. As a result, there is a pressing need for effective and efficient management strategies to reduce the burden of CAD and its complications.

[009] The WHO emphasized the significance of following prescribed medication to effectively manage medical conditions and derive maximum benefits from treatment. However, there is a concerning level of non-adherence to secondary prevention, particularly in post-ACS patients, in both developed and underdeveloped countries, increasing the risk of life-threatening events.

[0010] A number of different tools and techniques used for remote patient monitoring of cardiac patents are described in prior arts.

[0011] Prior art document IN 201847020076 discloses a mobile application which can be used for monitoring and management of users or patients with various health or disease conditions. Software system provides a platform with which the medical histories, the recent conditions and real-time measurement data for the patient can be organized and shared among various people who are involved in the caring of the patient. In addition to data sharing in a secured, private networking environment, the platform integrates the essential functions for people in the various caregiver’s groups to communicate with each other in real-time so as to collaborate on the caring of the patient.

[0012] Prior art document 201811029994 discloses device and methods for preventing heart attack and cardiac arrests of patient. The device and methods for preventing heart attack and cardiac arrests of patient comprise of a microcontroller, a blood pressure sensor, a sugar level detecting sensors, a body temperature sensor, a camera unit, a GPS unit, a power unit, a GSM unit, a ECG, a EMG, a heartbeat sensor, mobile objects and a computer implemented methods. The microcontroller is ATmega 908 and GSM unit further comprise of a cloud server. The microcontroller receives the sensors data and transmit to the mobile objects through the computer implemented device using the GSM unit.

[0013] Prior art document IN 201941053797 discloses a heart disease predicting system using Machine learning technology monitors and predicts heart disease in real time. The system comprises a controller unit, Wi-Fi module, a temperature, humidity and pulse rate sensors to sense and transmit the data to cloud. The sensor transmits the measured data to cloud in every 10 seconds. A software application is integrated or linked with heart disease predicting system to display the real time sensor acquired data on the screen of smartphone.

[0014] There is a need of innovative, patient-centered, action-oriented digital health intervention with continuous monitoring of cardiovascular health and adherence by patient's cardiologist and health coaches which further include globally approved medical devices, suite of lab tests, personalized diet and fitness plans and access to emergency services.

SUMMARY OF THE INVENTION
[0015] The inventors of this invention herein have recognized a need in the art for innovative, patient-centered, action-oriented digital health intervention for patients suffering from cardiac diseases.

[0016] According to one aspect of the disclosure, which can be combined with any other aspect, embodiment, or combination(s) of aspects and/or embodiments of the present disclosure, relates to a system for providing comprehensive cardiac care to patients having heart disease comprising:
computer program or software application operating on an electronic device;
physiological data acquisition devices;
at least one doctor or cardiologist;
optionally, a dietician and/or a health coach
wherein, the computer program or software application comprises:
a triaging module; and
a behavioral management system.

[0017] According to one aspect of the disclosure, which can be combined with any other aspect, embodiment, or combination(s) of aspects and/or embodiments of the present disclosure, relates to a system for providing comprehensive cardiac care to patients having heart disease comprising:
computer program or software application operating on an electronic device;
physiological data acquisition devices;
at least one doctor or cardiologist;
optionally, a dietician and/or a health coach
wherein, the computer program or software application comprises:
a triaging module; and
a heart health score; and
optionally, a behavioral management system.

[0018] According to one aspect of the disclosure, which can be combined with any other aspect, embodiment, or combination(s) of aspects and/or embodiments of the present disclosure, relates to system for providing comprehensive cardiac care to patients having heart disease comprising:
computer program or software application operating on an electronic device;
physiological data acquisition devices;
at least one doctor or cardiologist;
optionally, a dietician and/or a health coach
wherein, the computer program or software application comprises:
a triaging module; and
a heart attack prediction module; and
optionally, a behavioral management system.

[0019] Another aspect of present invention is to provide computer program or software application comprising a triaging module for generating alerts in which said triaging module comprises an algorithm that will triage the readings in different categories on the basis of value coming from physiological data acquisition devices, patient’s comorbidities and/or the laboratory vital reports from laboratory tests.

[0020] In yet another aspect, the triaging module comprises an algorithm runs on the data point to estimate whether the value is within the acceptable range or is off range and needs to be reported to the treating cardiologist for a comment on course of action to be taken by the patient. In further aspect, the algorithm is capable of comparing the value in a rule based manner against a set of threshold value and said threshold values are defined by the algorithm based on each cohort of users across different archetypes based on their comorbidities, age and other factors.

[0021] In yet another aspect of present invention is to provide computer program or software application comprising heart health score or heart attack prediction module which comprising the artificial intelligence or machine learning algorithm that capable of predicting the heart attack or other cardiac conditions by identifying trends of what kind of patient cohorts are resulting in off range value more frequently. Such a predictive algorithm is capable to take into account several factors including but not limited to demographic of the user such as age, gender, Co-morbidities like hypertension(HTN), diabetes(DM), chronic kidney disorder(CKD) and other co-morbidities, trend of several vital parameters originating from devices such as blood pressure, resting heart rate, weight/BMI, blood glucose, blood oxygen saturation(SPO2), continuous heart rate, activity levels, sleep time etc, lab vitals such as Low-density lipoprotein (LDL), hemoglobin (Hb or Hgb), creatinine (CR), fasting blood sugar (FBS or fasting glucose), post prandial blood sugar (PPBS), hemoglobin A1C (HbA1C) etc. and other factors.

[0022] In yet another aspect of present invention is to provide computer program or software application comprising heart health score or heart attack prediction module which comprising the artificial intelligence or machine learning algorithm that capable of generating alerts to the patients or cardiologist and/or medical professional and/or caregiver based on the triaging values and health score or heart attack prediction.

[0023] Another aspect of present invention is to provide computer program or software application comprising smart task list prioritization and behavioral management system which comprising the algorithm that is capable of generating in-app nudges on medication reminder, vital alerts, reminders for appointment for teleconsultation with doctor or coach, reminders for lab tests to be taken, reminders for medicines to be ordered, reminders for physical exercise or walking, reminders on diet and meal and recommendations on diet and fitness. Furthermore, the said algorithm is capable to order and display to the user in a manner taking into account several factors such as status of task, past trend of update of task, priority of task category, timing of task and other factors.

[0024] Another aspect of present invention is to provide a method of triaging comprising:
acquiring the values from physiological data acquisition devices
optionally, acquiring the values from laboratory tests
comparing the value with the threshold value
and
sending an alert
wherein, triaging is based on rule based algorithm.

[0025] In yet another aspect of present invention is to provide a method of predicting cardiac disease comprising,
collecting the data
identifying previous trends of data
analyzing co-relation of data and
predicting the likelihood of occurrence of a cardiac disease
wherein a method involves the use of rule based predictive algorithm.

BRIEF DESCRIPTION OF DRAWINGS
[0026] FIG. 1 shows Digital Therapeutics program flowchart for ACS/CAD patients
[0027] FIG. 2 shows Medication adherence at 3 months
[0028] FIG. 3 shows Trends of changes in systolic, DBP and heart rate

DETAILED DESCRIPTION OF THE INVENTION
[0029] Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention, which may be embodied in a manner not expressly described. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the various disclosures and claims provided herein.

[0030] Reference throughout this specification to “an aspect”, “another aspect” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, appearances of the phrase “in an embodiment”, “in another embodiment” and similar language throughout this specification may all, but not necessarily do, refer to the same embodiment.

[0031] The terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such a process or method. Similarly, one or more devices or sub-systems or elements or structures or components proceeded by "comprises... a" does not, without more constraints, preclude the existence of other devices or other sub-systems or other elements or other structures or other components or additional devices or additional sub-systems or additional elements or additional structures or additional components.

[0032] Throughout the description and claims of this specification, the singular encompasses the plural unless the context otherwise requires. In particular, where the indefinite article is used, the specification (which term encompasses both the description and the claims) is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.

[0033] Unless otherwise defined, all technical and scientific terms used herein have the meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The systems, methods, and examples provided herein are only illustrative and not intended to be limiting.

[0034] For the purposes of the present invention, the term “digital health intervention” is defined as the use of digital, mobile and wireless technologies to support the achievement of health objectives.

[0035] For the purposes of the present invention, the term “remote monitoring” or “remote patient monitoring” or “remotely” are used interchangeably and refers to a method encompasses the use of text, audio, video and other telecommunication technologies to monitor patient status at a distance.

[0036] For the purposes of the present invention, the term “application” refers to a platform on any electronic device, preferably mobile smartphone device. An application is computer program or software or set of algorithms designed to run on a mobile device or a computer such as a phone, personal computer (PC), desktop, tablet, or watch.

[0037] For the purposes of the present invention, the term “Internet” refer to a global system of interconnected computer networks that use the standard Internet protocol suite (TCP/IP) to serve billions of users worldwide. It is a network of networks that consists of millions of private, public, academic, business, and government networks, of local to global scope, that are linked by a broad array of electronic, wireless and optical networking technologies. The Internet carries an extensive range of information resources and services, such as the inter-linked hypertext documents of the World Wide Web (WWW.) and the infrastructure to support email. The communications infrastructure of the Internet consists of its hardware components and a system of software layers that control various aspects of the architecture.

[0038] For the purposes of the present invention, the term “patient” or “user” are used interchangeably and refers to user of the application on the platform, who is a patient having or had a cardiovascular disorder.

[0039] For the purposes of the present invention, the term “doctor” or “cardiologist” are used interchangeably and refers to a health professional. In one embodiment, the health professional is heart specialist doctor, cardiologists, heart surgeon or general practitioner.

[0040] For the purposes of the present invention, the term “medical professional” refers to a nurse, nursing technician, nursing assistant, pharmacist or any health professional.

[0041] For the purposes of the present invention, the term “coach” or “dietician” or “nutrition coach” are used interchangeably and refers to any person or group of persons who guides patient to facilitate the inclusion of healthy eating behaviors. In one embodiment, “coach” or “diet coach” or “nutrition coach” comprises a dietician who does periodic check-ins with the patient and family to guide on the correct diet and lifestyle practices to monitor the progress of the patient.

[0042] For the purposes of the present invention, the term “caregiver” refer to a person who is providing care and supporting the patient in their recovery journey. In one embodiment, “caregiver” comprises nurse, family members, relatives, neighbors, friends, personal nurses, household helpers, nursing homes, medical practitioner and professional care teams.

[0043] For the purposes of the present invention, the term “heart attack” or “acute coronary syndrome” or “ACS” are used interchangeably and refers to the condition result from a sudden blockage in coronary artery and sudden, reduced blood flow to the heart. In one embodiment, “heart attack” or “acute coronary syndrome” or “ACS” is a first or subsequent heart attack to the patient. In a preferred embodiment a heart attack is subsequent heart attack.

[0044] For the purposes of the present invention, the term “nerve center” refer to a group of people or team that consists of account managers who personally handle the journey of the patients.

[0045] For the purposes of the present invention, the term “account executive” or “ACE” refer to a person or group of persons assigned to take care of any future queries and is/are a point of contact for patient.

[0046] For the purposes of the present invention, the term “Onboarding team” to a group of people or team for onboarding doctors and patients onto the platform by setting up the health profile.

[0047] For the purposes of the present invention, the term “physiological data acquisition device” or “device” are used interchangeably and refer to the set of devices connected to an electronic device. In one embodiment, term “physiological data acquisition device” or “device” comprises sensors for measuring the bio vitals of patient’s body and transmitting this data to electronic device. In one embodiment, the “physiological data acquisition device” or “device” is capable for transmitting this data to electronic device via any wired or wireless mode, more particularly through a wireless network preferably via a near field connection technology which could typically be over BLUETOOTH® but may also extend to other forms enabled by internet.

[0048] For the purposes of the present invention, the term “program” or “computer program” or “algorithm” are used interchangeably and refer to a finite set of instructions which, if followed, accomplish a particular task.

[0049] In some embodiments, the term “program” can also mean an overall ecosystem for management of cardiovascular disease.

[0050] For the purposes of the present invention, the term “artificial intelligence or “machine learning algorithm” refer to a set of algorithms that is fed with structured data in order to complete a task without being programmed how to do so.

[0051] For the purposes of the present invention, the term “triaging” or “triage” are used interchangeably and refer to the method of selection and classification of data. In one embodiment the selection and classification of data is done by the program or computer program or algorithm or artificial intelligence or machine learning algorithm.

[0052] For the purposes of the present invention, the term “nudges” or “In-app nudges” are used interchangeably and refer to contextual push notification that is aimed at deriving action from receivers in particular for medication and behavioral adherence.

[0053] One of the embodiment of present invention is a system for providing comprehensive cardiac care to patients having heart disease comprising:
computer program or software application operating on an electronic device;
physiological data acquisition devices;
at least one doctor or cardiologist;
optionally, a dietician and/or a health coach
wherein, the computer program or software application comprises:
a triaging module; and
a behavioral management system.

[0054] Another embodiment of present invention is a system for providing comprehensive cardiac care to patients having heart disease comprising:
computer program or software application operating on an electronic device;
physiological data acquisition devices;
at least one doctor or cardiologist;
optionally, a dietician and/or a health coach
wherein, the computer program or software application comprises:
a triaging module; and
a heart health score; and
optionally, a behavioral management system.

[0055] Another embodiment of present invention is a system for providing comprehensive cardiac care to patients having heart disease comprising:
computer program or software application operating on an electronic device;
physiological data acquisition devices;
at least one doctor or cardiologist;
optionally, a dietician and/or a health coach
wherein, the computer program or software application comprises:
a triaging module; and
a heart attack prediction module; and
optionally, a behavioral management system.

Heart diseases-
[0056] In one embodiment, the present invention provides method for comprehensive cardiac care to the patients having heart disease which includes but not limited to the conditions such as ischemic heart disease, cerebrovascular disease, hypertensive heart disease, peripheral vascular disease, rheumatic heart disease, cardiomyopathies, coronary artery disease (CAD), cardiac arrest, heart attack, angina pectoris, myocardial infraction, congestive heart failure, stroke, congenital heart disease, acute coronary syndrome (ACS) and arrhythmias. In a preferred embodiment of the invention, the heart disease is acute coronary syndrome (ACS) or a heart attack. Further, in preferred embodiment, the invention provides method for comprehensive cardiac care to the patients having a risk of second or subsequent heart attacks.

[0057] In one embodiment, a cardiac disease is heart attack.

Electronic device-
[0058] In one embodiment, the electronic device is a computing devices, such as servers, desktop computers, laptop computers, tablet computers, personal digital assistants (PDA), smartphones, mobile phones, smart devices, appliances and sensors.

[0059] In one embodiment, the electronic device is a mobile phone device more particularly a smartphone device which can be configure to transmit or receive the data through a Global System for Mobile Communications (GSM), Code Division Multiple Access (CDMA), Long Term Evolution (LTE) network, cellular networks like 2G, 3G, 4G, 5G, Wi-Fi network, Wi-Fi hotspots, broadband, satellite connections, Local area network (LAN), cellular data, BLUETOOTH® or an Ad-hoc network created with neighboring wireless terminals. Preferably, electronic device is capable to transmit or receive the data through a wireless network preferably via a near field connection technology which could typically be over BLUETOOTH®.

[0060] As used herein a mobile device includes, but is not limited to, a smartphone, such as Apple's iPhone®, other portable electronic devices, such as Apple's iPod Touches®, Apple's iPads®, and mobile devices based on Google's Android® operating system, and any other portable electronic device that includes software, firmware, hardware, or a combination thereof that is capable of at least receiving the signal, decoding if needed, exchanging information with a transaction server. Typical components of mobile device may include but are not limited to persistent memories like flash ROM, random access memory like SRAM, internal storage, a camera, a battery, chip or processor, LCD driver, a display, a touchscreen or a touchpad, a cellular antenna, a speaker, a BLUETOOTH® circuit, sensors such as accelerometer, gyroscope, digital compass, proximity Sensor and WIFI circuitry, where the persistent memory may contain programs, applications, and/or an operating system for the mobile device.

[0061] A mobile device in one embodiment is having features including but not limited to an internet connectivity, Global Positioning System (GPS), mobile browser, Wireless synchronization with other devices, such as laptop or desktop computers, ability to download applications and run them independently, video calling, Email, voice-activated virtual assistant, social media, cloud storage, PDF reader, payment systems, calendar, GPS navigation, hotspot, short messaging service (SMS) or text messaging, app store etc. A mobile device is capable of download the application from play store like Google play or app store or any other method and run the application.

A system of connected physiological data acquisition device-
[0062] In one embodiment, physiological data acquisition devices comprise sensors for measuring the bio vitals of patient’s body and transmitting this data to electronic device. In one embodiment, the “physiological data acquisition device” or “device” is capable for transmitting this data to electronic device via any wired or wireless mode, more particularly through a wireless network preferably via a near field connection technology which could typically be over BLUETOOTH® but may also extend to other forms enabled by internet.

[0063] In one embodiment, physiological data acquisition devices enable sensor data to sync seamlessly between the device and the application in real time. In preferred embodiment, physiological data acquisition devices are capable to transfer the sensor data to the electronic device through BLUETOOTH® or near field connection technology and user is able to see the data in an application.

[0064] In one embodiment, physiological data acquisition devices are wearable device that can be worn by an individual and that has a back side that in some embodiments contacts a user's skin and a face side. Examples of wearable device include but are not limited to a patch, a wristwatch, a smartwatch, a band, a wristband, a chest band, a leg band, a sock, a glove, a foot pad, a head-band, an ear-clip, an ear phone, a shower-cap, an armband, an ear-ring, eye-glasses, sun-glasses, a belt, a sock, a shirt, a garment, a jewelry, a bed spread, a pillow cover, a pillow, a mattress, a blanket, each having one or more sensors and the like.

[0065] In one embodiment, physiological data acquisition devices are blood pressure monitoring device, smartwatch, pulse oximeter, glucometer, smart weighing scale, Electrocardiogram (ECG) measuring device and activity and heart rate tracking device.

[0066] In one embodiment, the physiological data acquisition devices comprise sensors for measuring the biovitals of patient’s body and transmitting the data to an electronic device.

[0067] In one embodiment, physiological data acquisition device is a smartwatch or smart band having a sensor which is capable to check or measure the biovitals including but not limited to heart rate (HR), physical activity, blood pressure, Sleep monitors, water consumption, calories consumed, calories burned, blood oxygen saturation level, respiration rate. The physical activity herein includes but not limited to walking, swimming, cycling, yoga and like. The smartwatch, such as Apple watch®, Samsung galaxy watch®, Fitbit watch®, iHealth watch or any other watch having sensor for collecting data. A smartwatch can run on operating system including but not limited to Google’s Wear OS or Android wear, Android, Apple’s Watch OS, IOS, RTOS, Tizen OS, Fitbit OS, Garmin Watch OS, Zepp OS or others. In preferred embodiment, smartwatch is used to track the physical activity and to track heart rate. Typical components of smartwatch may include but are not limited to persistent memories like flash ROM, random access memory like SRAM, internal storage, a camera, a battery, chip or processor, LCD driver, a display, a touchscreen or a touchpad, a cellular antenna, a speaker, a BLUETOOTH® circuit, sensors such as accelerometer, gyroscope, digital compass, proximity Sensor and WIFI circuitry, where the persistent memory may contain programs, applications, and/or an operating system for the smartwatch device. A smartphone is having features including but not limited to an internet connectivity, sensor for monitoring and measuring biovitals, sensors for tracking activity, Global Positioning System (GPS), mobile browser, Wireless synchronization with other devices, such as laptop or desktop computers, ability to download applications and run them independently, video calling, Email, voice-activated virtual assistant, social media, cloud storage, PDF reader, payment systems, calendar, GPS navigation, hotspot, short messaging service (SMS) or text messaging, app store etc.

[0068] In one embodiment, physiological data acquisition device is blood pressure monitoring device. Hemodynamic monitoring, which monitors the blood pressure and blood flow within the circulatory system. Blood pressure can be measured either invasively through an inserted blood pressure transducer assembly, or noninvasively with an inflatable blood pressure cuff. The blood pressure can be measured by any method including but not limited to the auscultatory method, oscillometric technique, ultrasound techniques, finger cuff method of Penaz, cuff-based oscillometric method or Smartphone / smartwatch-based cuffless blood pressure measurement. In preferred embodiment, a blood pressure monitor is used by cuff-based oscillometric method. In another embodiment, blood pressure monitoring device is capable to transfer the sensor data to the electronic device through BLUETOOTH® or near field connection technology and user is able to see the data in an application. A blood pressure monitor device, such as, Dr Trust BP monitor, Dr Morepen, Omron, iHealth track BP monitor etc. can be used. In a preferred embodiment blood pressure monitoring device is digital monitor and can be used by wrapping a cuff around the arm of patient and cuff will inflate by itself, after the cuff inflates, the device automatically will slowly let air out and user can see both systolic and diastolic blood pressure reading optionally along with pulse rate on the screen.

[0069] In one embodiment, physiological data acquisition device is glucometer for determining the approximate concentration of glucose in the blood. A glucometer can be of any type including blood testing with meters using test strips, self-monitoring of blood glucose (SMBG), noninvasive meters or continuous glucose monitors. In preferred embodiment, glucometer is a self-monitoring of blood glucose monitor. SMBG is an approach whereby people with diabetes measure their blood sugar (glycemia) themselves using a glycemic reader (glucose meter or glucometer). A self-monitoring of blood glucose monitor can be used with test strips, meter, lancet devices to obtain blood with a needle. SMBG works by having patients perform a number of glucose tests each day or each week. The test most commonly involves pricking a finger with a lancet device to obtain a small blood sample, applying a drop of blood onto a reagent strip, and determining the glucose concentration by inserting the strip into a reflectance photometer for an automated reading. Test results are then recorded in a logbook or stored in the glucose meter’s electronic memory. The measured readings can be Syncs seamlessly to the application via near field connection technology which could typically be over BLUETOOTH® but may also extend to other forms enabled by internet. The examples of glucometers commercially available are Dr Trust® USA glucose monitor, Dr Morepen® glucose monitor, OneTouch Verio Flex® meter, Contour Plus® One Blood Glucose Monitoring System, Accu-Chek® Instant Glucometer etc.

[0070] In one embodiment, physiological data acquisition device is oximeter or pulse oximeter to measure blood oxygen saturation level. A pulse oximeter is a device that is usually placed on a fingertip. It uses light beams to estimate the oxygen saturation of the blood and the pulse rate. Oxygen saturation gives information about the amount of oxygen carried in the blood. The pulse oximeter can estimate the amount of oxygen in the blood without having to draw a blood sample. Most pulse oximeters show two or three numbers. The most important number, oxygen saturation level, is usually abbreviated SpO2, and is presented as a percentage. The pulse rate (similar to heart rate) is abbreviated PR, and sometimes there is a third number for strength of the signal. Oxygen saturation values are between 95% and 100% for most healthy individuals, but sometimes can be lower in people with lung problems. Oxygen saturation levels are also generally slightly lower for those living at higher altitudes. The smartwatches or wearable devices or fitness bands can also have a features measuring blood oxygen saturation level. The measured readings can be Syncs seamlessly to the application via near field connection technology which could typically be over BLUETOOTH® but may also extend to other forms enabled by internet. The examples of oximeter are Beurer PO 60 Bluetooth® pulse oximeter, Omron® pulse oximeter, SLC® Fingertip Pulse Oximeter, Equinox® pulse oximeter, Dr Morepen® pulse oximeter etc.

[0071] In one embodiment, physiological data acquisition device is weighing scale. A weighing scale is to measure the weight of the person. The weighing scale can be mechanical scale or digital scale. In a preferred embodiment, weighing scale is digital scale which is having a sensor to measure weight of person along with other physiological data of the person. A weighing scale can determine body weight, body mass index (BMI), percent body fat, Muscle rate percentage, body water, bone mass, basal metabolic rate (BMR), metabolic age, percent visceral fat, percent subcutaneous fat, protein mass, muscle mass, weight without fat, obesity level etc. The smart weighing scale may use, along with the other methods, Bioelectrical Impedance Analysis (BIA) to determine body fat. The smart weighing scale has some sensors which sends a weak electrical impulse through the body. The impulse encounters varying levels of resistance or “impedance” from the different tissues and substances. The scales then use a mathematical formula that incorporates the value for electrical resistance with information about a person’s age, height, and gender. User can typically supply this information via a smartphone or other electronic device. The mathematical formula then estimates the relative percentages of total fat, muscle, water and bone density. The results can be recorded in a logbook or stored in the weighing scale’s electronic memory. The measured readings can be Syncs seamlessly to the application via near field connection technology which could typically be over BLUETOOTH® but may also extend to other forms enabled by internet. The examples of weighing scales commercially available are Wellue F5 digital Fitness, MI® Body Composite Scale, Lifetrons® Smart Weighing Scale, Sansui® Electronics Body Composition Scale, Dr.Trust® Smart Connect Weighing Scale, Lenovo® Smart Weighing Scale, ActoFit SmartScale etc.

[0072] In one embodiment, physiological data acquisition device is Electrocardiogram (ECG) monitor device. In one embodiment, an ECG monitor device is portable ECG monitor. Portable ECG monitors have built-in sensors that record the heart’s electrical activity. Some devices also come with built-in screens that allow users to view their heart rhythm. In some embodiments, a user can use a smart ECG monitor device that can record a medical-grade electrocardiogram (EKG) and the measured readings can be Syncs seamlessly to the application via near field connection technology which could typically be over BLUETOOTH® but may also extend to other forms enabled by internet. The examples of portable ECG monitors includes AliveCor MobileKardia 1L®, KardiaMobile® 6L, KardiaMobile® Card, EMAY Portable ECG Monitor etc.

[0073] In one embodiment, physiological data acquisition device is a ECG Cardiac Telemetry and Holter monitor. A Holter monitor typically involves the portable or wearable device having electrodes patches adhesively placed at certain points on the chest and abdomen that are connected by wires to a small, portable recording device. In one embodiment, ECG Cardiac Telemetry and Holter monitor is wireless electrocardiographic patch devices or wearable “on-body” ECG patch devices that continuously monitors ECG activity and other bio vitals using an adhesive patch that sticks to the chest. The ECG Cardiac Telemetry and Holter monitor or ECG patch can monitor or measure ECG, respiration rate, Oxygen saturation (SpO2), posture and activity, body temperature, Pulse transit time (PTT) etc. Adhesive ECG patch devices typically comprise a sensor system, a microelectronic circuit with recorder and memory storage, and an internal battery embedded in a relatively flexible synthetic matrix, resin, or other material. They are usually intended for medium-term use ranging from days to several weeks, depending on the device. The self-contained adherent unit typically has a low profile and can be affixed to the body surface, usually over the left upper chest area, by means of prefabricated adhesive material. The smart ECG patch is able to Sync the readings seamlessly to the application via near field connection technology which could typically be over BLUETOOTH® but may also extend to other forms enabled by internet. The examples of cardiac event monitor patch include SmartCardia® ScaAI patch.

[0074] In one embodiment, physiological data acquisition devices can have any operating system and can able to transfer the recorded data to the electronic device by any means of Near-field communication method including but not limited to BLUETOOTH®. In one embodiment, physiological data acquisition devices can have a custom integration via Application Programming Interface (API) or Software Development Kit (SDK) with the application which enables data to sync seamlessly between device and application in real time. In one embodiment, a user can feed the data manually by using an electronic device in an application.

Laboratory Tests:
[0075] In one embodiment, the laboratory tests can be any test performed in diagnostic and pathological laboratory including but not limited to blood tests, urine test, chest X-ray, ECHO test, stress test and Electrocardiogram (ECG). The blood test can be lipid profile, hemoglobin and complete blood count (CBC) test etc. The urine test can be creatinine test, test for sodium and potassium, protein, sugar, ketone and bilirubin etc. In one embodiment, user can feed the results or reports of laboratory tests manually into the application. Further, user can upload the results or reports of laboratory tests into the application in any digital format like PDF, Word file, Excel sheet, JPEG, PNG and GIF etc. In one embodiment, the results or reports of laboratory tests can be seen by patient, doctor, medical professional, coach, caregiver or nerve center on their application. In one embodiment, the laboratory tests are auto scheduled in the application with home pick-up facility.

Triaging module:
[0076] In one embodiment, present invention provides computer program or software application comprising a triaging module in which said triaging module comprises an algorithm that will triage the readings in different categories on the basis of value coming from physiological data acquisition devices, patient’s comorbidities and/or the laboratory vital reports from laboratory tests.

[0077] In another embodiment, the triaging module comprises an algorithm runs on the data point to estimate whether the value is within the acceptable range or is off range and needs to be reported to the treating cardiologist for a comment on course of action to be taken by the patient. In further embodiment, the algorithm is capable of comparing the value in a rule based manner against a set of threshold value and said threshold values are defined by the algorithm based on each cohort of users across different archetypes based on their comorbidities, age and other factors.

[0078] In another embodiment, the triaging module comprises a rule-based algorithm which determines the off range values from the threshold values and are classified into several identifiable categories such as Yellow High, Red High, Yellow Low and Red Low, as may be applicable against each parameter associated with the respective devices. These categories are determined by the extent to which a certain parameter is off range viz-a-viz the baseline that has been configured.

[0079] In another embodiment, the threshold values of triaging module are personalized set of values which are comparable to the bio-vital data input coming from a connected device system, laboratory reports, other comorbidities and other factors. In another embodiment, these thresholds are benchmarked from globally recognized thresholds that are published in reputed journals. In yet another embodiment, threshold values can be customized uniquely for every patient by their cardiologist.

[0080] As an example, the Blood Pressure Monitor gives the reading of blood pressure(BP) and the systolic and diastolic BP values are compared individually against the thresholds. If the yellow high and red high thresholds for systolic blood pressure(SBP) are 140 and 160 respectively, and the reading returned a value for SBP as 145, then the algorithm will determine the value to be off range and mark it as a “Yellow High” reading.

[0081] The off range readings are sent as an alert to any or all person including the treating cardiologist, patient, caregiver, Nerve center, coach or medical professional. The alert generation can be a phone call, text message, In-app alert, emergency siren, In-app nudges or anything that can grab the attention. In particular, the alerts are sent on the doctor’s electronic device having application and doctor can see the complete details of the reading taken by the patient along with the profile information, based on which they can diagnose the situation and convey the recommended course of action via the doctor application itself which the patient can then view and take appropriate next steps.

[0082] In one embodiment, present invention provides method of triaging comprising:
I. acquiring the values from physiological data acquisition devices
II. optionally, acquiring the values from laboratory tests
III. comparing the value with the threshold value
and
IV. sending an alert
wherein, triaging algorithm is based on artificial intelligence or machine learning platform.

[0083] In one embodiment, the triaging module comprises an algorithm that triage the readings in different categories.

[0084] In another embodiment, the triaging module comprises the algorithm to compare the biovitals value and laboratory test data with pre-configured threshold value in rule based manner wherein an algorithm generates an alert remotely to at least one doctor or caregiver.

[0085] In another embodiment, the threshold value is a benchmark value that is a standard value or customized uniquely by the doctor based on the comorbidities and age of patient.

Heart attack prediction module:
[0086] In one embodiment, present invention provides rule based predictive algorithm that becomes smarter as it come across the various scenarios of data coming from physiological data acquisition device, laboratory tests, other comorbidities, symptoms generally faced by patient, course of action suggested by doctor and other factors. This rule based predictive algorithm will evolve to start identifying trends of what kind of patient cohorts are resulting in off range value more frequently, or subsequent cardiac events. Based on the high confidence of trend identification, the predictive algorithm is capable to become personalized to an individual user to predict potential cardiac issues that the user could be having and suggest to take a course of action which would typically involve consulting their treating cardiologist. Based on the algorithm’s prediction, the application exhibits a heart health score which designate an overall health of heart and based on it doctor can recommend the course of action to patient.

[0087] In one embodiment, heart health score or heart attack prediction can be readily shared to the treating cardiologist, patient, caregiver, Nerve center, coach or medical professional as an alert. The alert generation can be a phone call, text message, In-app alert, emergency siren, In-app nudges or anything that can grab the attention. In particular, the alerts are sent on the doctor’s electronic device having application and doctor can see the complete details of the heart health score or heart attack prediction along with the profile information, based on which they can diagnose the situation and convey the recommended course of action via the doctor application itself which the patient can then view and take appropriate next steps.

[0088] In another embodiment, predictive algorithm would take into account several factors, including but not limited to,
I. Demographic of the user such as age, gender.
II. Co-morbidities like hypertension(HTN), diabetes Mellitus (DM), chronic kidney disorder(CKD) and other co-morbidities as identified by research to influence cardiac health.
III. Trend of several vital parameters originating from devices such as blood pressure, resting heart rate, weight/BMI, blood glucose, blood oxygen saturation(SPO2), continuous heart rate, activity levels, sleep time etc.
IV. Laboratory vitals such as LDL, Hb, Serum Cr., FBS, PPBS, HbA1C etc. which have an influence on cardiac health.
V. In addition, the algorithm incorporates the regularity of the user in performing all the activities and tasks on time as per the prescribed manner in the program.

[0089] Based on these, a proprietary model would then analyze for co-relation of the various factors with occurrence or non-occurrence of events and predict the likelihood of occurrence of a next event and suggest the user to consult with their treating doctor based on the findings.

[0090] In another embodiment, present invention provides method of predicting cardiac disease comprising:
I. collecting the data;
II. identifying previous trends of data;
III. analyzing co-relation of data and
IV. predicting the likelihood of occurrence of a cardiac disease,
wherein a method involves the use of rule based predictive algorithm.

[0091] In one embodiment, the computer program or software application further comprises heart attack prediction module wherein the heart attack prediction module comprises rule based predictive algorithm configured to access a data store, identify the trends of the data and apply a prediction model to predict a potential cardiac issue in future wherein prediction model is trained based on the historical data of biovitals received from physiological data acquisition devices, laboratory test data, comorbidities of patient, symptoms encountered by patients and previous trend of course of action suggested by doctor.

[0092] In another embodiment, the heart attack prediction module comprises a rule based predictive algorithm wherein an algorithm become personalized to an individual patient to predict potential cardiac issue wherein cardiac issue is heart attack.

[0093] In another embodiment, the heart attack prediction module comprises a rule based predictive algorithm wherein an algorithm generates a notification to display on the electronic device wherein a notification is a heart health score.

Behavioral management system:
[0094] In one embodiment, present invention provides smart task list prioritization and behavioral management system. This system has proprietary sorting algorithm and reminder system which can modify behavior of the user leading to better health outcomes. This proprietary sorting algorithm and reminder system ensures the completion of tasks which would result in better patient outcomes.

[0095] A task based behavior management system assigns specific tasks under several different categories, and smartly nudges the users of the application to complete them. The completion of the tasks across categories such as readings, diet plan, medicine reminders, exercise reminder, doctor and coach appointments, upcoming lab test order or medicine order ensures there is a modified behavior of the user leading to better health outcomes.

[0096] The application has a set of tasks created for the users of the application to perform, as recommended by the treating doctor or dietician or fitness coach at the time of their onboarding onto the program and personalized to their preferences, typically on a daily basis. These tasks are set of ordered cards which have specific purpose and instruction on them and lead with a call to action for a specific action to be performed by the user and when said action is completed, the task gets marked as done.

[0097] The cards are arranged into several color codes and are tagged on basis of priority such as,
I. Scheduled(White)
II. Active(White)
III. Overdue(Amber)
IV. Missed(Red)
V. Done(Green)

[0098] The cards involved in the application are of several type including but not limited to,
I. Vitals reading reminders
II. Medicine Reminders
III. Reminders for appointments for teleconsultation with doctor or coach
IV. Reminders for lab tests to be taken/medicines to be ordered
V. Reminders for physical exercise/walking
VI. Meal reminders
VII. Reminders for weekly follow up questions on diet

[0099] In another embodiment, present invention provides smart task list prioritization and behavioral management system having a proprietary sorting algorithm and reminder system which determines how the tasks are ordered and displayed to the user which makes the tasks more effectively consumed and induces a change in behavior where the users are performing their tasks as expected. This change in behaviors is known to eventually bring about an improvement in health outcomes.

[00100] The proprietary sorting algorithm and reminder system is able to display and order in a manner taking into account several factors such as the status of the tasks, the past trend of update of the task, the priority of the task category, timing of the task and other several factors which would make up the proprietary logic for display on the application to the user.

[00101] This display order and the types of tasks are known to impact the behavior of the users and bring about an improvement in health outcomes through better program adherence. The success of the program in delivering health outcomes is dependent on how good the logic is and how effectively it is able to drive adherence of users to completing the tasks. A smart task list prioritization and behavioral management system of the present invention ensure adherence to lifestyle changes and medication through nudges, providing actionable and personalized insights. It also ensures adherence to prescribed treatment using smart pillbox and behavior based engagement techniques.

[00102] In one embodiment, the behavioral management system comprises a sorting algorithm and reminder system wherein sorting algorithm and reminder system is configured to assign tasks and send reminder to the patient to complete the task wherein the reminders are vitals reading reminder, medicine reminder, reminder for appointment for teleconsultation with doctor, dietician or health coach, reminder for laboratory tests, reminder to order medicine, meal reminder and exercise reminder.

[00103] In another embodiment, the sorting algorithm and reminder system is configured to sort the tasks and display to the patient wherein sorting of tasks carried out by considering status of task, past trend, priority of task category and timing of task.

Platform for management of chronic cardiovascular disorders
[00104] In one embodiment, present invention provides a platform for management of chronic cardiovascular disorders. A platform is an overall ecosystem for helping users to manage their chronic cardiovascular disorders. The system has several parts that are connected and enabled by a cloud based platform to interact seamlessly.

[00105] The platform for management of chronic cardiovascular disorders comprises several parts. The cardiologist or a doctor can recommend patient or caregiver to take part into the program. During onboarding, the doctor clears all doubts of patients and tell all the advantages of the program and if the patient or caregiver has an interest, a counsellor approaches the patient and caregiver and explain program in detail. A counsellor is a member of onboarding team along with doctor and Account Executive (ACE).

[00106] A counsellor is any person having broad knowledge about the program and platform. If the patient or caregiver has further interest in the program, then doctor or counsellor fills the health profile of the patient which is used to design customized program for patient. A counsellor generates a customized package, collects payment from patient, help to download the application on user’s smartphone or any other electronic device and activates the account.

[00107] A counsellor hand over the physiological data acquisition devices to the patient or caregiver and help to set-up them. Counsellor help to log-in the application and give detailed demonstration of how to use the devices and application.

[00108] An ACE is a person or group of persons assigned to take care of any future queries and is/are a point of contact for patient. ACE gives a walk through the application and guide to use application along with their profile setup. ACE counsels about the alert system and emergency or SOS situation. ACE can guide in-person physically or through a teleconsulting by using techniques such as in-app video call feature or audio call or in-app text messaging etc.

[00109] A health coach and dietician guide the patient and caregiver for a healthy eating habits and motivate to do a regular exercise. health coach and dietician share a personalized diet and fitness plan and schedules a counselling and rehabilitation sessions.

[00110] A patient or caregiver can feed the symptoms in the application manually. For example, chest pain, chest tightness, chest pressure and chest discomfort, shortness of breath, pain, numbness, weakness or coldness in legs or arms, pain in the neck, jaw, throat, upper abdomen or back

[00111] In use, the physiological data acquisition devices measure the bio-vitals of the patients. This includes blood pressure monitor to track blood pressure, pulse oximeter to measure blood oxygen saturation (SPO2), smartwatch or smart band to track the heart rate variation in continuous basis and to track intensity and duration of activity, glucometer to check blood glucose level, smart weighing scale to check body weight and other body composition such as bone mass, percent body water, fluid retention, protein mass etc., handheld ECG device to continuously check electrocardiogram.

[00112] The data recorded by physiological data acquisition devices can syncs seamlessly to the application via near field connection technology which could typically be over BLUETOOTH® but may also extend to other forms enabled by internet. The recorded data can be seen by user, caregiver, doctor, counselor, ACE, nerve center etc.

[00113] The laboratory tests are carried out on the periodic basis as well as recommended by the doctor. The laboratory tests can be any test performed in diagnostic and pathological laboratory including but not limited to blood tests, urine test, chest X-ray, ECHO test, stress test and Electrocardiogram (ECG). The blood test can be lipid profile, hemoglobin and complete blood count (CBC) test etc. The urine test can be creatinine test, test for sodium and potassium, protein, sugar, ketone and bilirubin etc. In one embodiment, user can feed the results or reports of laboratory tests manually into the application. Further, user can upload the results or reports of laboratory tests into the application in any digital format like PDF, Word file, Excel sheet, JPEG, PNG and GIF etc. In one embodiment, the results or reports of laboratory tests can be seen by patient, doctor, medical professional, coach, caregiver or nerve center on their application. In one embodiment, the laboratory tests are auto scheduled in the application with home pick-up facility.

[00114] Based on the symptoms, bio-vital values obtained by physiological data acquisition device and laboratory results, a rule based algorithm which runs on the data point to estimate whether the value is within the acceptable range or is off range and needs to be reported to the treating cardiologist for a comment on course of action to be taken by the patient. The algorithm is capable of comparing the value in a rule based manner against a set of threshold value and said threshold values are defined by the algorithm based on each cohort of users across different archetypes based on their comorbidities, age and other factors.

[00115] Based on the triaging, the values and results are shown in different categories such as Yellow High, Red High, Yellow Low and Red Low which can be synced to cloud based platform and can be seen by doctor, caches, patient, caregiver, ACS or neve center.

[00116] The thresholds of triaging module are personalized set of values which are comparable to the bio-vital data input coming from a connected device system, laboratory reports, other comorbidities and other factors. These thresholds would be benchmarked from globally recognized thresholds that are published in reputed journals and further customized uniquely for every patient by their cardiologist.

[00117] The off range readings are sent as an alert to any or all person including the treating cardiologist, patient, caregiver, nerve center, coach or medical professional. The alert generation can be a phone call, text message, In-app alert, emergency siren, In-app nudges or anything that can grab the attention. In particular, the alerts are sent on the doctor’s electronic device having application and doctor can see the complete details of the reading taken by the patient along with the profile information, based on which they can diagnose the situation and convey the recommended course of action via the doctor application itself which the patient can then view and take appropriate next steps.

[00118] The doctor responds within the set timings specified for different red/yellow alerts for vitals and lab parameters. In case the doctor misses the timing to respond, ACE send reminder to the doctor. If the treating cardiologist or doctor is not available within the defined time period, SOS or emergency can be activated by the patient for red vitals and critical symptoms.

[00119] A proprietary triaging algorithm which triages the values recorded from the devices and relays any off range values to the treating cardiologist or doctor who then responds with the next best course of action that the patient may follow. The next best action advised by cardiologist or doctor may be but not limited to any of the following,
I. Do an immediate or scheduled teleconsultation
II. No action required
III. Come down for an in person consultation at clinic
IV. Take a bio-vital reading from one of the connected devices
V. Take a lab test and share the report
VI. Share an updated digital prescription for change in medication
VII. Write other advice to be followed over the chat interface in the application
VIII. Advise of SOS or emergency

[00120] In one of the embodiment, application has a set of tasks created for the users of the application to perform, as recommended by the treating doctor or coach or dietician at the time of their onboarding onto the program and personalized to their preferences, typically on a daily basis. The tasks are a set of ordered cards which have specific purpose and instruction on them and lead with a call to action for a specific action to be performed by the user. When said action is completed, the task gets marked as Done.

[00121] There is a proprietary logic which determines how the tasks are ordered and displayed to the user which makes the tasks more effectively consumed and induces a change in behavior where the users are performing their tasks as expected. This change in behaviors is known to eventually bring about an improvement in health outcomes. The tasks are of several categories and status types and a proprietary logic orders the tasks when displayed to the user in the application to achieve maximum program adherence.

[00122] To manage the adherence to the program, coach does regular check-ins with the patient to assess their dietary requirements and suggest plans for a diet that suits the user needs. Considering upon the bio-vital data, lab reports and other factors, nutrition coach can suggest a modification in overall eating habits and diet.

[00123] To manage the adherence to the program, nerve team checks in on a periodic basis if the user is not able to do the tasks set for them in the application, is not able to get timely feedback from the doctor in case of poor adherence and to resolve any other issues pertaining to devices, medicines orders and lab test orders.

[00124] Figure 1 represents Digital therapeutics program flowchart for ACS/CAD patients. This program consists of Mobile app integrated with connected devices (wireless activity and heart rate tracker, blood pressure monitor, pulse oximeter, glucometer, Smart weighing scale and ECG handheld). Integration of wireless devices allowed patients to measure and monitor their blood pressure, heart rate and physical activity. Patients received reminders on medications, lifestyle modifications and appointments.

[00125] This program has seven components- 1) Comprehensive and proactive monitoring with suite of auto-scheduled lab tests and teleconsultation with the treating cardiologists, 2) Adherence to lifestyle changes and medication through nudges, providing actionable, personalized insights and bite-sized competition 3) Caregiver involvement through training and dedicated caregiver app to get alerts and monitor vitals, 4) Personalized coaching and support from dedicated nutritionists and health coaches to help patient manage disease through diet and exercise plan which is contextual to patient's lifestyle, condition and preference, 5) Education modules on disease for the patient and care giver, 6) Emergency response system to help patient manage any cardiac emergencies. It also includes access to early detection system (symptoms based/auto triggered SOS button on fall detection, erratic heart rate) that alerts doctors and family members and triggers emergency protocol, 7) Access to ambulances equipped to handle cardiac events and pre-determined hospitals based on availability and 1st aid education.

Emergency or SOS activation:
[00126] In one embodiment, present invention provides emergency or SOS activation through the application. When patient experiences severe discomfort or Caregiver notices patient experience emergency level discomfort or doctor notices an emergency condition, an emergency or SOS protocol is activated in the program.

[00127] In one embodiment, an emergency or SOS activation is triggered manually or through auto-triggered SOS activation system.

[00128] In one embodiment, present invention provides emergency or SOS activation through auto-triggered SOS activation system. The auto-triggered SOS activation involves the detection of events including but not limited to fall detection, erratic heart rate detection etc.

[00129] In one of the embodiment, a patient or caregiver may connect to doctor or hospital on their own through the application via an audio call, text messaging or video call or teleconsultation or any other method of communication like simple phone call. The application has an in-app feature to directly call on the mobile phone of doctor or treating cardiologist. In such case, doctor or caregiver notify ACE that the patient has been admitted and ACE is activated. ACE follows up and see if hospitalization done properly. ACE activates Do Not Disturb (DND) protocol to stop check-ins.

[00130] In one of the embodiment, in emergency or SOS, patient or caregiver may press emergency or SOS button provided in the application through which patient or caregiver can call their treating cardiologist through application itself. If the call is not connected, then patient has other options to retry a call or to seek a nerve center’s assistance.

[00131] In one of the embodiment, in emergency or SOS, patient or caregiver may press emergency or SOS button provided in the application and patient or caregiver can able to see the list of preferred hospitals and contact details to connect with them through application itself. The list of preferred hospitals shown in the application are nearby hospitals or clinics to the patient’s location. The patient’s location can be accessed through Global Positioning System (GPS) or any other suitable method.

[00132] In emergency or SOS, patient or caregiver may press “Call Nerve Centre” button provided in the application and patient or caregiver is connected with the nerve center for assistance. A person of nerve center team answer call and checks the authenticity of patient, their current location and confirms need of emergency service.

[00133] Upon verification of a genuine intent for SOS nerve center notifies the treating cardiologist about the patient’s emergency situation and proceeds to activate emergency protocol in which nerve center connects with the Emergency Department (ED) of preferred or 2-3 nearest hospitals to the location of patient.

[00134] The nerve center confirms the emergency situation in a hospital and communicate to caregiver or patient in this regard. Hospital confirm the location of patient and dispatches ambulance to patient location.

[00135] The nerve center notifies a primary doctor or treating cardiologist regarding the emergency condition of patient and update doctor periodically. The biovitals, lab reports and any other physiological data can be shared to the doctor handling emergency condition.

[00136] In one embodiment, present invention provides access to health mall through an application wherein a patient or caregiver can order medicines prescribed by doctor, physiological data acquisition devices, health supplements which are delivered at the patients mentioned address in the application.

[00137] In one embodiment, present invention provides financial support to the patient to continue therapy which includes but not limited to insurance, loans, micro financing, no cost EMI etc.

[00138] The weighted model underpinning the method according to embodiments herein was the outcome of a clinical study, which will now be explained. The following should be regarded as an explanatory and non-limiting example.

[00139] The objective and primary endpoint of the study was to evaluate the efficacy of the software-driven digital therapeutic intervention on cardiovascular events, vitals, adherence to lifestyle changes and medication among patients with CAD or post-coronary intervention, with the goal of reducing complications and hospitalization.

[00140] The study was a pilot, single-centred, prospective and real-world evidence cohort study performed with a 3-month follow-up period, to introduce a clinical evidence-based, software-driven therapeutics intervention in patients with CAD and/ post-coronary interventions.

[00141] A total of 30 patients were enrolled. This study conducted in compliance with protocol approved by institutional ethics committee (IEC), in applicability to good clinical practice (GCP) guidelines.

[00142] Patients were included in this study after meeting the eligibility criteria as 1) Patients aged 18 years or older; 2) Patients who have a documented diagnosis of CAD and or who underwent coronary intervention either as an emergency or an elective procedure; 3) Patients willing to comply with the follow-up plan set as per the real world scenario; 4) Patient who has read and signed the informed consent form (ICF); 5) Patients who have basic reading skills (English/Hindi/Marathi).

[00143] LYFE (by Lupin digital health Pvt. Ltd.) is a personalized digital heart care program that allows patients to monitor and manage heart health. This program consists of Mobile app integrated with connected devices (wireless activity and heart rate tracker, blood pressure monitor, pulse oximeter, glucometer, Smart weighing scale and ECG handheld). Integration of wireless devices allowed patients to measure and monitor their blood pressure, heart rate and physical activity. Patients received reminders on medications, lifestyle modifications and appointments.

[00144] The major outcomes were to compare mean change in systolic (SBP) and diastolic blood pressure (DBP) and heart rate from baseline at 1 month and 3 months, adherence to medication, incidence of MACE, all-cause readmission and adherence to lifestyle modification like exercise and diet at 3 months.

[00145] Statistical analyses were performed at a=0.05 significance level. Continuous data were presented with mean and standard deviation (SD) and for categorical data the number and percentage of patients within each category were reported. Student pair t-test were used to compare significant change between the baseline and follow up values. P value of less than 0.05 was considered to indicate a statistically significant difference. The statistical analyses were done using SPSS software version 25.0 (IBM Corp., Armonk, NY, USA) and Microsoft corporation (2019), Microsoft excel.

[00146] The study enrolled a total of 30 patients for a period of 3 months. Out of 30 patients, 27 (93.3%) were males with a mean age of 53.2±12.1 years. The mean height of the patients was 166.7±7.9 cm and the mean weight was 72.9±13.7 kg, with a mean BMI of 26.3±5.0. Twenty-five (83.3%) of 30 patients did not smoke and 18 (60%) did not consume alcohol. Eighteen (60%) patients preferred a non-vegetarian diet while the remaining 12 (40%) preferred a vegetarian diet. 12 (40%) patients did not have any comorbidities; however, hypertension and type 2 diabetes were present in 9 (30%) and 6 (20%) patients, respectively, while 3 (10%) patients had both conditions. Patients had a mean SBP and DBP of 128.8±20.0 mmHg and 83.8±8.7 mmHg with a mean HR of 81.9±12.1 bpm. Diagnosis revealed the presence of STEMI, NSTEMI, and unstable angina in the study participants.

[00147] Overall 16 (53.3%) patients suffered single-vessel coronary artery lesions, 6 (20.0%) suffered double-vessel lesions and 3 (10%) suffered triple-vessel lesions. PCI was performed on 22 (73.3%) patients, CABG on 2 (6.7%) and thrombolysis on 1 (3.3%) patient while 3 (16.7%) patients had no interventions and were managed on medications (Table 1).

Table 1: Patients baseline characteristics (n=30).

Characteristics Values: Mean ± SD N (%)
Demographics
Age (years) 53.2±12.1
Weight (kgs) 72.9±13.7
Height (cm) 166.7±7.9
BMI (kg/m2) 26.3±5.0
Male 28 (93.3)
Female 2 (6.7)
Smoking
Current smoker 4 (13.3)
Former smoker 1 (3.3)
Never smoker 25 (83.3)
Alcohol
Current drinker 11 (36.7)
Former drinker 1 (3.3)
Never drinks 18 (60)
Dietary preferences
Non-vegetarian 18 (60)
Vegetarian 12 (40)
Comorbidities
Hypertension (HTN) 9 (30)
Type 2 diabetes mellitus (T2DM)) 6 (20)
Both (HTN+T2DM) 3 (10)
None 12 (40)
Vitals
SBP (mm Hg) 128.8±20.0
DBP (mm Hg) 83.8±8.7
HR (bpm) 81.9±12.1
Initial diagnosis
STEMI 23 (76.7)
NSTEMI 1 (3.3)
Unstable angina 1 (3.3)
Others 5 (16.7)
Coronary artery lesions
Single vessel 16 (53.3)
Double vessel 6 (20)
Triple vessel 3 (10)
Other 5 (16.7)
Interventions
PCI 22 (73.3)
CABG 2 (6.7)
Thrombolysis 1 (3.3)
Neither 3 (16.7)

Abbreviations: BMI- Body Mass Index, SBP-Systolic blood pressure, DBP-Diastolic blood pressure, HR-Heart rate, bpm-beats per minute, STEMI- ST-segment elevation myocardial infarction, NSTEMI- non-ST segment elevation myocardial infarction, PCI- post-percutaneous coronary intervention, CABG- Coronary artery bypass graft.

[00148] A total of 27 (90%) of the patients remained active throughout the study period with 23 (76.7%) of the patients responding on track and 4 (13.3%) patients with delayed response. Two (6.7%) patients stopped their journey in between while 1 (3.3%) patient was reported to be inactive (Table 2).

Table 2: Compliance to LYFE (Digital program) at 3 months (n=30).

Status Values N (%)
Active 27 (90)
On track 23 (76.7)
Delayed 4 (13.3)
Drop out (Total) 3 (10)
Inactive 1 (3.3)
Journey stopped 2 (6.7)

[00149] Figure 2 represents the medication adherence at 3 months. Out of 30 patients involved in the trial, 90% were adherent to medication while the remaining 10% were non-adherents or dropouts.

[00150] The mean change in SBP, DBP and HR of the active study participants were analyzed from baseline to 1 month and at the conclusion of the 3-month study (Table 3). The mean difference for SBP was 8±17.2 (p=0.018) and for DBP it was 3.7±7.3 (p=0.010) at the end of the 1 month. Furthermore, we found that the improvement continued with the mean difference of 7.8±10.9 (p=0.001) for SBP and 3.7±5.7 (p=0.002) for DBP, at end of the study period.

Table 3: Change in mean SBP, DBP and HR from baseline to 1 month, 2 months and 3 months.

Parameters N Value, Mean ± SD P Value
Baseline 1st month/ 30 days Change (Baseline-month 1)
SBP 29 128.8±20.4 120.7±15.8 8±17.2 0.018*
DBP 29 84.0±8.9 80.3±9.2 3.7±7.3 0.010*
HR 29 82.0±12.3 82.0±9.8 0±10.3 0.971
Baseline 3rd month/90 days Change (Baseline-month 3)
SBP 27 126.5±18.3 118.7±16.7 7.8±10.9 0.001*
DBP 27 83.2±8.5 79.4±9.9 3.7±5.7 0.002*
HR 27 81.3±12.2 83.1±11.1 -1.8±9.1 0.311
SBP-Systolic blood pressure, DBP-Diastolic blood pressure, HR-Heart rate, bpm- beats per minute, *p value is significant if <0.05.

[00151] With regards to cardiovascular events, 1 (3.3%) patient experienced a stroke while no major bleeding events or death were recorded during the study (Table 4).

[00152] Patients who achieved SBP<140 mm Hg and DBP<90 mm Hg at 3-month follow-up time were considered as patients with blood pressure under control. At the end of the study, 25 (83.3%) patients had controlled blood pressure while 2 (6.7%) patients had it beyond the range (Table 4, Figure 3). Additionally, with respect to activity status, 27 (90%) patients were active and 3 (10%) were inactive throughout the study period (Table 4).

Table 4: Status of cardiac events, blood pressure, and level of activity (n=30).

Clinical outcomes Values N (%)
Cardiovascular events
Cardiovascular death 0 (0)
Major bleeding events 0 (0)
Stroke or TIA 1 (3.3)
None 26 (86.7)
Missing/ drop out 3 (10)
Blood pressure status at 3 months
Under control 25 (83.3)
Beyond range 2 (6.7)
Missing/drop out 3 (10)
Activity level at 3 months
Active/step count 27 (90)
Non-active 3 (10)
TIA-transient ischemic attack.

[00153] Among the CAD and post-PCI patients, “LYFE” digital therapeutic program resulted in significantly high medication adherence and achieving blood pressure under control range. Results from initial 90 days are encouraging and promising to achieve sustained results over longer period of time, which may lead to reduced complications and better patient outcomes. By leveraging the power of digital health, the study results suggest that DTx program will help patients to develop effective and scalable strategies for CAD/ACS post-PCI management in coming days.
,CLAIMS:
1. A system for providing comprehensive cardiac care to patients having heart disease comprising:
computer program or software application operating on an electronic device;
physiological data acquisition devices;
at least one doctor or cardiologist;
optionally, a dietician and/or a health coach
wherein, the computer program or software application comprises:
a triaging module; and
a behavioral management system.

2. The system according to claim 1, wherein the heart disease is ischemic heart disease, cerebrovascular disease, hypertensive heart disease, peripheral vascular disease, rheumatic heart disease, cardiomyopathies, coronary artery disease, cardiac arrest, heart attack, angina pectoris, myocardial infraction, congestive heart failure, stroke, congenital heart disease, acute coronary syndrome (ACS), coronary artery disease (CAD) and arrhythmias.

3. The system according to claim 1, wherein the electronic device is a computing devices, such as servers, desktop computers, laptop computers, tablet computers, personal digital assistants (PDA), smartphones, mobile phones, smart devices, appliances and sensors.

4. The system according to claim 1, wherein the physiological data acquisition devices comprises sensors for measuring the biovitals of patient’s body and transmitting the data to an electronic device.

5. The system according to claim 1, wherein the physiological data acquisition devices are blood pressure monitoring device, smartwatch, pulse oximeter, glucometer, smart weighing scale, Electrocardiogram (ECG) measuring device and activity and heart rate tracking device.

6. The system according to claim 1, wherein the triaging module comprises an algorithm that triage the readings into different categories.

7. The system according to claim 1, wherein the triaging module comprises the algorithm to compare the biovitals value and laboratory test data with pre-configured threshold value in rule based manner wherein an algorithm generates an alert remotely to at least one doctor or caregiver.

8. The system according to claim 7, wherein the threshold value is a benchmark value that is a standard value or customized uniquely by the doctor based on the comorbidities and age of patient.

9. The system according to claim 1, wherein the computer program or software application further comprises heart attack prediction module wherein the heart attack prediction module comprises rule based predictive algorithm configured to access a data store, identify the trends of the data and apply a prediction model to predict a potential cardiac issue in future wherein prediction model is trained based on the historical data of biovitals received from physiological data acquisition devices, laboratory test data, comorbidities of patient, symptoms encountered by patients and previous trend of course of action suggested by doctor.

10. The system according to claim 9, wherein the heart attack prediction module comprises a rule based predictive algorithm wherein an algorithm become personalized to an individual patient to predict potential cardiac issue wherein cardiac issue is heart attack.

11. The system according to claim 10, wherein the heart attack prediction module comprises a rule based predictive algorithm wherein an algorithm generates a notification to display on the electronic device wherein a notification is a heart health score.

12. The system according to claim 1, wherein the behavioral management system comprises a sorting algorithm and reminder system wherein sorting algorithm and reminder system is configured to assign tasks and send reminder to the patient to complete the task wherein the reminders are vitals reading reminder, medicine reminder, reminder for appointment for teleconsultation with doctor, dietician or health coach, reminder for laboratory tests, reminder to order medicine, meal reminder and exercise reminder.

13. The system according to claim 12, wherein the sorting algorithm and reminder system is configured to sort the tasks and display to the patient wherein sorting of tasks carried out by considering status of task, past trend, priority of task category and timing of task.

14. The system according to claim 1, wherein the computer program or software application further comprising an emergency or SOS activation wherein an emergency or SOS activation triggered manually or through auto-triggered SOS activation system.

15. A system for providing comprehensive cardiac care to patients having heart disease comprising:
computer program or software application operating on an electronic device;
physiological data acquisition devices;
at least one doctor or cardiologist;
optionally, a dietician and/or a health coach
wherein, the computer program or software application comprises:
a triaging module; and
a heart health score; and
optionally, a behavioral management system.

16. A system for providing comprehensive cardiac care to patients having heart disease comprising:
computer program or software application operating on an electronic device;
physiological data acquisition devices;
at least one doctor or cardiologist;
optionally, a dietician and/or a health coach
wherein, the computer program or software application comprises:
a triaging module; and
a heart attack prediction module; and
optionally, a behavioral management system.