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NCT06738381

Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease

Recruiting now NA Last updated 21 February 2025
What this trial tests

NA trial testing Digital intervention and motivational counselling in Atheroscleroses, Coronary in 300 participants. Currently enrolling.

Timeline
3 February 2025
Primary endpoint
20 December 2026
20 December 2026

Quick facts

Lead sponsorVestre Viken Hospital Trust
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment300
Start date3 February 2025
Primary completion20 December 2026
Estimated completion20 December 2026
Sites1 location across Norway

Drugs / interventions tested

Conditions studied

Sponsor

Vestre Viken Hospital Trust

Who can join

18 and older, any sex, with Atheroscleroses, Coronary or Atheroscleroses, Cerebral. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Atheroscleroses, Coronary

Currently open trials in the same condition.

Other Vestre Viken Hospital Trust trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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