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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
240
PreventiPlaque is an app that supports patients with atherosclerotic plaque by strengthening their adherence.
Change in cardiovascular risk profile
Measured via SCORE2 (Systematic Coronary Risk Evaluation) risk calculator
Time frame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Change in LifeSimple7-Score
Measured by Score released by the American Heart Association (AHA)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
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