Digital Secondary Prevention in Cardiovascular Disease

Atherosclerotic Plaque Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05096637
• Other study ID #: 20-9157-BO
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2021
• Est. completion date: July 2023

Study information

• Verified date: October 2021
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerotic Plaque
• Cardiovascular Diseases
• Plaque, Atherosclerotic

Intervention

Other:
• PreventiPlaque App
PreventiPlaque is an app that supports patients with atherosclerotic plaque by strengthening their adherence.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-centered evaluation of the intervention-app	assessed via Mobile Application Rating Scale: user version (uMARS)	end of study after 12 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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