Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease

Not Applicable

Recruiting

• Conditions: Atheroscleroses, Coronary; Atheroscleroses, Cerebral; Atherosclerotic Ischemic Disease

• Registration Number: NCT06738381
• Lead Sponsor: Vestre Viken Hospital Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-17
• Status Verified: 2025-02
• Study Start: 2025-02-03
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2026-12-20
• Study Completion: 2026-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Attended follow-up visits in primary healthcare	From baseline to weeks 6-8 and 26	Between-group differences in the proportion attending follow-up visits at primary care physicians and community-based healthy life centres assessed by patient self-report and from medical records
Attended follow-up visits in specialist healthcare	From baseline to weeks 6-8 and 26	Between-group differences in the proportion attending follow-up visits at cardiac rehabilitation programs and at hospital outpatient visits assessed by patient self-report and from hospital medical records

Secondary Outcome Measures

Name	Time	Method
Change in the SMART2 risk score	From baseline to weeks 26 and 52	Between-group change in the validated SMART2 risk score
Changes in lipid profile	From baseline to weeks 26 and 52	Between-group changes in total cholesterol, HDL-cholesterol and LDL-cholesterol in blood
Changes in systolic blood pressure	From baseline to weeks 26 and 52	Between-group changes in systolic blood pressure
Changes in HbA1c	From baseline to weeks 26 and 52	Between-group change in HbA1c levels in blood
Changes in smoking status	From baseline to weeks 26 and 52	Between-group differences in the proportion who report smoking abstinence

Trial Locations

Locations (1)

Vestre Viken Trust Drammen hospital; 🇳🇴 Drammen, Buskerud, Norway