Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease
Recruiting now · Not applicable
Conditions studied: Atheroscleroses, Coronary, Atheroscleroses, Cerebral, Atherosclerotic Ischemic Disease
In brief
Atherosclerotic cardiovascular disease (ASCVD) remains a leading cause of morbidity and mortality worldwide and in Norway. Approximately 50% of the patients admitted to hospitals with an acute ASCVD event has had a previous event. The high number of patients being readmitted to hospitals with new ASCVD events is to a large degree explained by poor control of established risk factors such as high LDL-cholesterol, high blood pressure (BP), diabetes, obesity, smoking, and lack of physical activity, as well as poor adherence to evidence-based medication. This pragmatic, open-label proof-of-concept study conducted at three secondary care hospitals will randomly assign patients hospitalized with an ASCVD event to either: (i) brief advice, tailored discharge information to general practitioners, and a nurse-led outpatient visit (control), or (ii) the same interventions as (i) plus a single in-hospital motivational counselling session and access to a digital platform for a 6 months period with patient information/videos and an individualized treatment plan and follow-up plan. The primary end point will be between-group differences in the proportion who report having attended follow-up visits in primary (primary care physicians and community-based healthy life centres) and specialist (cardiac rehabilitation programs, hospital outpatient visits) healthcare after 8 weeks and 6 months follow-up. Secondary end points will be change in the SMART2 risk score and cardiovascular risk factors between baseline and 6 and 12 months follow-up. Exploratory end points will be changes in adherence to cardiovascular drugs, self-care behaviour, health literacy, patient activation, and quality of life.
Key facts
- Study ID
- NCT06738381
- Run by
- Vestre Viken Hospital Trust
- People needed
- 300
- Starts
- 2025-02-03
- Expected to finish
- 2026-12-20
- Last updated by the study team
- 2025-02-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Vestre Viken Trust Drammen hospital — Drammen, Buskerud, Norway (enrolling)
Full record on ClinicalTrials.gov
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