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Digital Secondary Prevention in Cardiovascular Disease

Primary Purpose

Atherosclerotic Plaque

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PreventiPlaque App
Sponsored by
University Hospital, Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Atherosclerotic Plaque

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    control group

    intervention group

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    Change in cardiovascular risk profile
    Measured via SCORE2 (Systematic Coronary Risk Evaluation) risk calculator

    Secondary Outcome Measures

    Change in LifeSimple7-Score
    Measured by Score released by the American Heart Association (AHA)
    Change in LDL-cholesterol
    measured in mg/dl
    Change in body weight
    measured in kg
    Change in blood pressure
    measured in mmHg
    Reported physical activity
    measured via self-report question
    Change in cigarette dependency
    asses via Fagerstrom Test for Cigarette Dependence
    Change in reported medication adherence
    assessed via self-report question
    Satisfaction with outpatient care
    assessed via questionnaire "Satisfaction in outpatient care)

    Full Information

    First Posted
    October 15, 2021
    Last Updated
    October 15, 2021
    Sponsor
    University Hospital, Essen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05096637
    Brief Title
    Digital Secondary Prevention in Cardiovascular Disease
    Official Title
    PreventiPlaque - Digital Secondary Prevention in Cardiovascular Disease to Improve Therapy Adherence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2021 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    July 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital, Essen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atherosclerotic Plaque

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Patients receive the best medical care according to current guideline recommendations without access to the app
    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    PreventiPlaque App
    Intervention Description
    PreventiPlaque is an app that supports patients with atherosclerotic plaque by strengthening their adherence.
    Primary Outcome Measure Information:
    Title
    Change in cardiovascular risk profile
    Description
    Measured via SCORE2 (Systematic Coronary Risk Evaluation) risk calculator
    Time Frame
    baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
    Secondary Outcome Measure Information:
    Title
    Change in LifeSimple7-Score
    Description
    Measured by Score released by the American Heart Association (AHA)
    Time Frame
    baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
    Title
    Change in LDL-cholesterol
    Description
    measured in mg/dl
    Time Frame
    baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
    Title
    Change in body weight
    Description
    measured in kg
    Time Frame
    baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
    Title
    Change in blood pressure
    Description
    measured in mmHg
    Time Frame
    baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
    Title
    Reported physical activity
    Description
    measured via self-report question
    Time Frame
    baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
    Title
    Change in cigarette dependency
    Description
    asses via Fagerstrom Test for Cigarette Dependence
    Time Frame
    baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
    Title
    Change in reported medication adherence
    Description
    assessed via self-report question
    Time Frame
    baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
    Title
    Satisfaction with outpatient care
    Description
    assessed via questionnaire "Satisfaction in outpatient care)
    Time Frame
    baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
    Other Pre-specified Outcome Measures:
    Title
    Patient-centered evaluation of the intervention-app
    Description
    assessed via Mobile Application Rating Scale: user version (uMARS)
    Time Frame
    end of study after 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Digital Secondary Prevention in Cardiovascular Disease

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