Digital Secondary Prevention in Cardiovascular Disease

University Hospital Essen

Status: Unknown

Conditions: Atherosclerotic Plaque

Treatments: Other: PreventiPlaque App

Study type: Interventional

Funder types: Other

Identifiers

NCT05096637

20-9157-BO

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

control group

No Intervention group

Description:

Patients receive the best medical care according to current guideline recommendations without access to the app

intervention group

Experimental group

Description:

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.

Treatment:

Other: PreventiPlaque App