Digital Secondary Prevention in Cardiovascular Disease
- Conditions
- Atherosclerotic Plaque
- Interventions
- Other: PreventiPlaque App
- Registration Number
- NCT05096637
- Lead Sponsor
- University Hospital, Essen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 240
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention group PreventiPlaque App 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.
- Primary Outcome Measures
Name Time Method Change in cardiovascular risk profile baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months Measured via SCORE2 (Systematic Coronary Risk Evaluation) risk calculator
- Secondary Outcome Measures
Name Time Method Change in cigarette dependency baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months asses via Fagerstrom Test for Cigarette Dependence
Change in body weight baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months measured in kg
Reported physical activity baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months measured via self-report question
Change in blood pressure baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months measured in mmHg
Change in LifeSimple7-Score baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months Measured by Score released by the American Heart Association (AHA)
Change in LDL-cholesterol baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months measured in mg/dl
Change in reported medication adherence baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months assessed via self-report question
Satisfaction with outpatient care baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months assessed via questionnaire "Satisfaction in outpatient care)