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
About this trial
This is an interventional supportive care trial for Atherosclerotic Plaque
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
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
NCT ID
NCT05096637
First Posted
October 15, 2021
Last Updated
October 15, 2021
Sponsor
University Hospital, Essen
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
Learn more about this trial
Digital Secondary Prevention in Cardiovascular Disease
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