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Clinical Trials/NCT05096637
NCT05096637
Unknown
Not Applicable

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

University Hospital, Essen0 sites240 target enrollmentNovember 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atherosclerotic Plaque
Sponsor
University Hospital, Essen
Enrollment
240
Primary Endpoint
Change in cardiovascular risk profile
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2021
End Date
July 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Essen
Responsible Party
Principal Investigator
Principal Investigator

Julia Lortz

PD Dr. med.

University Hospital, Essen

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

Outcomes

Primary Outcomes

Change in cardiovascular risk profile

Time Frame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months

Measured via SCORE2 (Systematic Coronary Risk Evaluation) risk calculator

Secondary Outcomes

  • Change in cigarette dependency(baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months)
  • Change in body weight(baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months)
  • Reported physical activity(baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months)
  • Change in blood pressure(baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months)
  • Change in LifeSimple7-Score(baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months)
  • Change in LDL-cholesterol(baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months)
  • Change in reported medication adherence(baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months)
  • Satisfaction with outpatient care(baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months)

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