A Digital Care Solution for Coronary Artery Disease Patients

Study Overview
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Brief Summary
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This is a single center, randomized clinical trial (RCT), recruiting 200 patients with coronary artery disease (CAD) who are currently receiving standard care treatment at the cardiology department of Landspítali University Hospital in Reykjavik, Iceland. The RCT will determine whether an interactive health app that supports lifestyle changes can positively impact disease progression and quality of life of CAD patients. Patients will be randomized to receive either the standard of care (SoC) alone or SoC with the addition of the digital app. The digital app will include remote patient monitoring and a patient support program specific for CAD patients. The investigators will study the impact of the digitally delivered lifestyle intervention and remote monitoring on disease progression and on the patients' quality of life.

Detailed Description
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Cardiovascular disease (CVD) is the leading cause of death worldwide, with an estimated number of 17.9 million deaths each year. Coronary artery disease (CAD) is the most common form of CVD and is caused by plaque buildup (atherosclerosis) in the walls of the coronary arteries that supply blood to the heart. The plaques consist of deposits of cholesterol, fat, calcium and other substances. Atherosclerosis of the coronary arteries reduces blood flow to the heart and can eventually result in a myocardial infarction. Lifestyle-related risk factors are known to play an important role in the development of CAD and CVD in general and many of these risk factors are modifiable. The most important modifiable cardiovascular risk factors are an unhealthy diet, physical inactivity, smoking use, and excessive use of alcohol. Improvements in these modifiable risk factors can significantly lower the risk of recurrent events in CVD patients. Many clinical trials have shown that lifestyle interventions focused on for instance improving diet, physical activity, weight and waist circumference reduce cardiovascular risk scores. Also, recurrence of cardiac events can be reduced by lifestyle interventions as smoking cessation was associated with 43% reduction of recurrent myocardial infarction, and regular exercise and diet modifications reduced the risk of recurrent myocardial infarction by 48%. Exercise intervention reduced mortality by 27% and diet intervention reduced mortality by 26%. While on the other hand reduced physical activity has been shown to increase the risk of cardiac death in CAD patients. Lifestyle modification has not only been shown to improve quality of life but is also cost-effective. Lifestyle intervention is recommended by clinical guidelines, but a gap exists between recommendations and what is being implemented in clinical practice. Finding simple ways to incorporate lifestyle intervention to standard CAD care could undoubtedly improve patient outcomes and the disease burden. Because of the widespread ownership of smartphones, digital applications hold promise for providing lifestyle modification support to large numbers of people in a format that is readily accessible at almost any time. Approximately two-thirds of the world's population owns a smartphone, and in 2019 there were 204 billion app downloads. Considering the evidence, the use of digital applications seems supported. However, currently, there is still limited data to draw from on the effectiveness of digitally delivered remote monitoring and patient support programs for CAD patients. As a result, more data is needed. In this study, Sidekick Health's newly developed digital care solution, including remote patient monitoring (RPM) and a patient support program (PSP) specifically developed for CAD patients, will be tested. Comparing the effect of adding a digital solution to the standard of care (SoC), this study will investigate the impact of a holistic, digitally delivered lifestyle intervention and remote monitoring on disease progression and on the CAD patient's quality of life. The aim of this study is to test the effectiveness of improving clinical outcomes and quality of life by using the Sidekick Health's CAD digital program in combination with SoC compared to SoC alone.

Official Title
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A Randomized-controlled Trial Evaluating a Digital Care Solution (Sidekick, SK-121) for Coronary Artery Disease Patients at Landspítali University Hospital

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: A digital care solution for patients with Coronary Artery Disease
* Other: Standard of care for patients with Coronary Artery Disease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults diagnosed with coronary artery disease Fluent in verbal and written Icelandic Capacity to give informed consent Capacity to operate a smartphone Exclusion Criteria: Not owning a smartphone compatible with the Sidekick Health app or not willing to have it installed on their device Not able or willing to comply with study intervention/scheduled measures and visits Having another serious medical condition (e.g., cancer, endocarditis, heart failure (EF<40%), history of cardiac arrest) Active alcohol or drug abusers

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
Interventional Model Description: Single center prospective randomized open blinded end-point (PROBE)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Care Solution group<br>Participants will be instructed to download the SKH mobile app to which the participants will have access for 12 months, and the participants will receive an access code to activate the SKH CAD program. The aim of the program is to empower self-assessment of CAD symptoms as well as positive lifestyle change by gamification, altruistic rewards, and engaging content with relevant tasks or missions to be completed. Beyond this, all patients in the interventional arm will also receive standard of care as defined below for the control arm. | Device: A digital care solution for patients with Coronary Artery Disease<br>* A digital care solution that provides remote patient monitoring and a patient support program specifically developed for CAD patients. The digital care solution empowers self-assessment of CAD symptoms as well as positive lifestyle change by gamification, altruistic rewards, and engaging content with relevant tasks or missions to be completed.<br>* Other names: SK-121;Other: Standard of care for patients with Coronary Artery Disease<br>* Follow-up and continuous care as usual in outpatient care (i.e., Standard of Care). The participants in the Standard of Care - control group will also receive an information leaflet about relevant lifestyle modifications for CAD.<br>|
| Active Comparator: Standard of Care - control group<br>The participants in the Standard of Care - control group will receive an information leaflet about relevant lifestyle modifications for CAD. After baseline measurements and data collection, follow-up and continuous care will be as usual in outpatient care (i.e., Standard of Care). | Other: Standard of care for patients with Coronary Artery Disease<br>* Follow-up and continuous care as usual in outpatient care (i.e., Standard of Care). The participants in the Standard of Care - control group will also receive an information leaflet about relevant lifestyle modifications for CAD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of recurrent Coronary Artery Disease | Difference in change in total score of the Second Manifestations of ARTerial disease (SMART) risk score between the intervention and control groups. The SMART Risk Score is based on 13 demographic and clinical parameters, the resulting SMART Risk Scores range from 0 to 100%, with a lower score representing a lower risk. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAD-specific health status | Difference in change in the total score of the 7-item Seattle Angina Questionnaire - 7 (SAQ-7) between the intervention and control groups. The SAQ-7 consists of a self-reported list with 7 questions (1a-c and 2-5) where one can choose between six (questions 1a to 3) or five (questions 4 and 5) answers by ticking boxes. The answers of 1a and 1b are on Likert scales where 1 represents extremely limited to 6 limited for other reasons or did not do the activity. The answers of 2 and 3 are on Likert scales where 1 represents 4 or more times per day to 6 none over the past 4 weeks. The answers of question 4 are on a Likert scale where 1 represents it has extremely limited my enjoyment of life to 5 it has not limited my enjoyment of life at all. The answers of question 5 are on a Likert scale where 1 represents not satisfied at all to 5 completely satisfied. Scores are on a scale of 7 to 39 with low scores denoting the worst and high scores the best possible status. | 12 months | 
| Burden of Coronary Artery Disease | Difference in burden of Coronary Artery Disease between intervention and control group as measured by (costs of) number of Coronary Artery Disease-related visits to emergency room, hospital, and the cardiology department. | 12 months | 
| Medication adherence | Difference in self-assessed medication adherence between intervention and control group as measured by the 8-item Morisky Medication Adherence Scale (MMAS-8). The MMAS-8 is an 8-item structured, self-reported medication adherence measure. The total score on the MMAS-8 has a range from 0 to 8.0. The 3 categorical Likert Scale is: low adherence is <6, medium adherence is 6 to <8, and high adherence is 8. | 12 months | 
| Patients self-care and disease knowledge | Difference in self-care and disease knowledge between intervention and control group as measured by the self-assessed Coronary Artery Disease Education Questionnaire - Short Version (CADE-Q SV). The CADE-Q SV is a 20-item questionnaire where one can choose between three answers by ticking boxes True, False, or I don't know. Each correct answer is given 1 point. The scores on the CADE-Q SV range from 0 to 20, with low scores denoting the worst and high scores the best possible self-care and disease knowledge. | 12 months | 
| Smoking status | Difference between intervention and control group in self-reported smoking status | 12 months | 
| Depression, anxiety, and stress levels | Difference in change in the total score of the 21-item Depression, Anxiety and Stress Scale (DASS21) questionnaire between the intervention and control group. Each question on the DASS21 has a Likert scale of 4 options where 0 represents did not apply to me to 3 applied to me very much. The scores on the subscales range from 0 to 63, and low scores indicate a better mental health status. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, digital application, lifestyle change, remote monitoring, clinical outcome, quality of life