Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2021-11-30
2023-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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control group
Patients receive the best medical care according to current guideline recommendations without access to the app
No interventions assigned to this group
intervention group
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.
PreventiPlaque App
PreventiPlaque is an app that supports patients with atherosclerotic plaque by strengthening their adherence.
Interventions
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PreventiPlaque App
PreventiPlaque is an app that supports patients with atherosclerotic plaque by strengthening their adherence.
Eligibility Criteria
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Inclusion Criteria
* 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
* severe valve disease
* no german knowledge
* unwillingness to user the app and/or undergo diagnostic procedures
18 Years
79 Years
ALL
No
Sponsors
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University Hospital, Essen
OTHER
Responsible Party
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Julia Lortz
PD Dr. med.
References
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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.
Other Identifiers
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20-9157-BO
Identifier Type: -
Identifier Source: org_study_id