Digital Secondary Prevention in Cardiovascular Disease

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

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 Overview

• Status: Not yet recruiting
• Conditions: Atherosclerotic Plaque
• Intervention / Treatment: Other: PreventiPlaque App

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; Patients receive the best medical care according to current guideline recommendations without access to the app
Experimental: intervention group; 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.	Other: PreventiPlaque App; PreventiPlaque is an app that supports patients with atherosclerotic plaque by strengthening their adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-centered evaluation of the intervention-app	assessed via Mobile Application Rating Scale: user version (uMARS)	end of study after 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Essen

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Cardiovascular Diseases; Plaque, Atherosclerotic
• Other Study ID Numbers: 20-9157-BO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No