Clinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients

Study Overview
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Brief Summary
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Cardiovascular diseases (CVD) are the leading cause of death worldwide, taking an estimated 17.9 million lives each year. The reduction of CVD-related mortality and morbidity is a key global health priority. Cardiac rehabilitation (CR) is a multi-factorial and comprehensive intervention in secondary prevention, being recommended in international guidelines. Core components in CR include patient assessment, physical activity counseling, nutritional counseling, risk factor control, patient education, and psychosocial management. CR has been shown to reduce mortality, hospital readmissions, costs, as well as to improve physical fitness, quality of life, and psychological well-being. However, despite the recommendations and proven benefits, acceptance and adherence remain low. Access to health technologies in all primary and secondary healthcare facilities can be essential to ensure that those in need receive treatment and counseling. Using mobile health (mHealth) solutions may contribute to more personalized and tailored patient recommendations according to their specific needs. Also, these technologies contribute to increasing the flexibility, quality, and efficiency of the services provided by health institutions. Time constraints, patient overpopulation, and complex guidelines require alternative solutions for real-time patient monitoring. Rapidly evolving e-health technology combined with clinical decision support systems (CDSS) provides an effective solution to these problems. There are several computerized CDSS for managing chronic diseases; however, to the best of our knowledge, there are none for the e-management of patients with CVD. The purpose of this transdisciplinary research project is to develop and evaluate a user-friendly, comprehensive CDSS for remote monitoring of CVD patients. The CDSS will suggest a monitoring plan for the patient, advise the mHealth tools (apps and wearables) adapted to patient needs, and collect data. The primary outcome will be the reduction of recurrent cardiovascular events (a composite of cardiovascular rehospitalization or urgent consultation, unplanned revascularization, cardiovascular mortality, or worsening heart failure).

Official Title
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Clinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients: Promoting Self-Management and Adherence to Treatment

Conditions
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Decision Support Systems, Clinical

Intervention / Treatment
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* Combination Product: mHeart.4u


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients attending the cardiology outpatient clinics after the onset of acute cardiac event OR Patients attending the cardiology outpatient clinics who are engaged in a structured Cardiac Rehabilitation program Be able to communicate with the researcher Exclusion Criteria: Participants will be excluded if they have New York Heart Association class III/IV heart failure, terminal disease, or significant non-cardio vascular disease exercise limitations.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mHeart.4u<br>The mHEART.4U intervention includes the use of an online Clinical Decision Support System (CDSS) for remote patient monitoring. According to the patient needs and profile, the CDSS will suggest a monitoring plan for the patient. The mHEART.4U kit will include mobile apps and wearables, such as heart rate, blood pressure, peripheral oxygen saturation (SpO2), sleep and step trackers, symptoms, lifestyle self-monitoring tools, medication reminders or motivational resources. The intervention length will be 6 months and will take into account the most recent guidelines on Cardiac Rehabilitation. | Combination Product: mHeart.4u<br>* The mHeart.4U is a multiple-components intervention entailing the adoption and use of technological devices and self-management recommendations tailored to behavioural modifications (e.g. physical exercise and dietary patterns)<br>|
| No Intervention: Standard care<br>This arm will receive treatment and care according to the prevailing practice at each of the cardiac hospital units. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent cardiovascular event rates | This outcome is a composite of cardiovascular rehospitalization or urgent visit, unplanned revascularization, cardiovascular mortality, or worsening heart failure | Two measurement timepoints: 3-month (T1) and the 6-month (T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score (assessed by the MacNew Heart Disease Health-related Quality of Life questionnaire) | The MacNew Heart Disease Health-related Quality of Life questionnaire consists of 27 items which fall into three domains (physical limitations domain scale, emotional function domain scale, and social function domain scale). Scoring of the MacNew is straight-forward. The maximum possible score in any domain is 7 (high quality of life) and the minimum is 1 (poor quality of life). | Two measurement timepoints: 3-month (T1) and the 6-month (T2) | 
| Adherence to treatment score (assessed by the Therapeutic Self-care Scale) | The Therapeutic Self-care Scale total score (from 0 to 60 points) corresponds to a high level of performance in therapeutic self-care. The scale is designed to assess patients' ability to engage in four aspects of self-care: taking medications as prescribed by the doctor; identifying and managing symptoms; performing activities of daily living; and managing changes in condition. | Two measurement timepoints: 3-month (T1) and the 6-month (T2) | 
| Body Mass Index (in Kg/m^2) | The Body Mass Index is a measure of body fat based on height and weight. It is calculated by a person's weight in kilograms divided by the square of height in meters. | Two measurement timepoints: 3-month (T1) and the 6-month (T2) | 
| Health-Promoting Lifestyle score (assessed by the Health-Promoting Lifestyle Profile-II) | The Health-Promoting Lifestyle Profile-II consists of 52 health-promoting behavior items that are categorized into six subscales: health responsibility, spiritual growth, physical activity, interpersonal relationships, nutrition, and stress management. Each behavior is measured from 1 (never) to 4 (regularly). The total score of the scale ranges from 52 to 208 (higher scores represents healthier lifestyles). | Two measurement timepoints: 3-month (T1) and the 6-month (T2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decision Support Systems, Clinical, Telemedicine, cardiac rehabilitation