NCT06738381

Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease

Individually Tailored Digital Secondary Prevention After Hospitalization for Atherosclerotic Cardiovascular Disease: a Randomized Proof-of-concept Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Vestre Viken Hospital Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atheroscleroses, Coronary
• Atheroscleroses, Cerebral
• Atherosclerotic Ischemic Disease

Interventions

Type	Name	Description
BEHAVIORAL	Digital intervention and motivational counselling	A single sesstion of motivational interviewing and access to a digital plattform for a six months period

Timeline

• Start date: 2025-02-03
• Primary completion: 2026-12-20
• Completion: 2026-12-20
• First posted: 2024-12-17
• Last updated: 2025-02-21

Locations

1 site across 1 country: Norway