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Digital Secondary Prevention in Cardiovascular Disease

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05096637
Enrollment
240
Registered
2021-10-27
Start date
2021-11-30
Completion date
2023-07-31
Last updated
2021-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic Plaque

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.

Interventions

OTHERPreventiPlaque App

PreventiPlaque is an app that supports patients with atherosclerotic plaque by strengthening their adherence.

Sponsors

University Hospital, Essen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in cardiovascular risk profilebaseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 monthsMeasured via SCORE2 (Systematic Coronary Risk Evaluation) risk calculator

Secondary

MeasureTime frameDescription
Change in LifeSimple7-Scorebaseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 monthsMeasured by Score released by the American Heart Association (AHA)
Change in LDL-cholesterolbaseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 monthsmeasured in mg/dl
Change in body weightbaseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 monthsmeasured in kg
Change in blood pressurebaseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 monthsmeasured in mmHg
Change in cigarette dependencybaseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 monthsasses via Fagerstrom Test for Cigarette Dependence
Change in reported medication adherencebaseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 monthsassessed via self-report question
Satisfaction with outpatient carebaseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 monthsassessed via questionnaire Satisfaction in outpatient care)
Reported physical activitybaseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 monthsmeasured via self-report question

Other

MeasureTime frameDescription
Patient-centered evaluation of the intervention-append of study after 12 monthsassessed via Mobile Application Rating Scale: user version (uMARS)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026