Digital Secondary Prevention in Cardiovascular Disease

NCT05096637 | Unknown

• 1 other identifier: 20-9157-BO
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atherosclerotic Plaque

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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 body weight

  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

• Reported physical activity

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

Other Outcomes (1)

• Patient-centered evaluation of the intervention-app

  end of study after 12 months

Study Arms (2)

control group

NO INTERVENTION

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

intervention group

EXPERIMENTAL

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

Interventions

PreventiPlaque App OTHER

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

intervention group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Essen: lead

Related Publications (1)

• Ullrich G, Bauerle A, Jahre LM, Paldan K, Rosemeyer J, Kalaitzidis C, Rammos C, Teufel M, Rassaf T, Lortz J. Impact of visual presentation of atherosclerotic carotid plaque on cardiovascular risk profile using mHealth technologies. NPJ Digit Med. 2025 Jan 22;8(1):47. doi: 10.1038/s41746-024-01423-y.

  PMID: 39843925 DERIVED

MeSH Terms

Conditions

Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 27, 2021
• Study Start: November 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share