Clinical trial NCT05096637: Digital Secondary Prevention in Cardiovascular Disease
Official title: PreventiPlaque - Digital Secondary Prevention in Cardiovascular Disease to Improve Therapy Adherence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atherosclerotic Plaque
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in cardiovascular risk profile
timeFrame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Secondary outcomes:
measure: Change in LifeSimple7-Score
timeFrame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
measure: Change in LDL-cholesterol
timeFrame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
measure: Change in body weight
timeFrame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
measure: Change in blood pressure
timeFrame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
measure: Reported physical activity
timeFrame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
measure: Change in cigarette dependency
timeFrame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
measure: Change in reported medication adherence
timeFrame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
measure: Satisfaction with outpatient care
timeFrame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Other outcomes:
measure: Patient-centered evaluation of the intervention-app
timeFrame: end of study after 12 months
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