Digital Secondary Prevention in Cardiovascular Disease

Study Overview
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Brief Summary
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Although advances in knowledge of the prevention, diagnosis and treatment of atherothrombosis are encouraging, cardiovascular diseases (CVD), with acute and chronic ischemic heart disease in particular, remain a major cause of disability and premature death throughout the world. Cardiac rehabilitation (CR) and secondary prevention are coordinated multidimensional evidence-based strategies that aim to assist patients with acute and chronic ischemic heart disease return to an active and satisfying life and to prevent the recurrence of further cardiac events. Since CR is time limited after an acute event, secondary prevention proposes a continuum where care is provided for the rest of a person's life according to the existence of cardiovascular risk factors. Secondary prophylaxis is fundamental for the recovery of the patient, but in most cases, it is only insufficiently implemented. To ensure adequate resources for the delivery of health care and to further improve the level of care, care-delivery models need to be changed in a way that patients themselves become more involved in their own care. Mobile health (mHealth) is a rapidly growing health delivery methodology with the potential to impact on health care research, health care delivery and health outcomes. Therefore, the aim of the study is to determine the impact of plaque visualization using a digital intervention on treatment adherence to improve the cardiovascular risk profile. Participants will be randomized into two groups: intervention group and control group. Participants of the control group receive the best medical care according to current guideline recommendations without access to the app. Participants of the intervention group receive the best medical care according to current guideline recommendations with full access to the Smartphone application at time of study begin until the completion of the follow-up period of 12 months. The access to the app includes access to relevant findings including ultrasound images of the carotid artery, lipid profile, blood pressure values, and weight.

Official Title
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PreventiPlaque - Digital Secondary Prevention in Cardiovascular Disease to Improve Therapy Adherence

Conditions
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Atherosclerotic Plaque

Intervention / Treatment
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* Other: PreventiPlaque App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ultrasound evidence of atherosclerotic plaque in one or both carotid arteries Own a smartphone and know how to use apps presumed life expectancy of more than one year willing to comply with the protocol and provide written informed consent Exclusion Criteria: congestive heart failure with NYHA (New York Heart Association classification) III-IV symptoms severe valve disease no german knowledge unwillingness to user the app and/or undergo diagnostic procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Patients receive the best medical care according to current guideline recommendations without access to the app | |
| Experimental: intervention group<br>Patients receive the best medical care according to current guideline recommendations with full access to the app. This includes access to relevant findings including ultrasound images of the carotid artery, lipid profile, blood pressure values, and weight. | Other: PreventiPlaque App<br>* PreventiPlaque is an app that supports patients with atherosclerotic plaque by strengthening their adherence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiovascular risk profile | Measured via SCORE2 (Systematic Coronary Risk Evaluation) risk calculator | baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LifeSimple7-Score | Measured by Score released by the American Heart Association (AHA) | baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months | 
| Change in LDL-cholesterol | measured in mg/dl | baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months | 
| Change in body weight | measured in kg | baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months | 
| Change in blood pressure | measured in mmHg | baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months | 
| Reported physical activity | measured via self-report question | baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months | 
| Change in cigarette dependency | asses via Fagerstrom Test for Cigarette Dependence | baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months | 
| Change in reported medication adherence | assessed via self-report question | baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months | 
| Satisfaction with outpatient care | assessed via questionnaire Satisfaction in outpatient care) | baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months |