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Clinical Trials/NCT06738381
NCT06738381
Recruiting
Not Applicable

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

Vestre Viken Hospital Trust1 site in 1 country300 target enrollmentFebruary 3, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atheroscleroses, Coronary
Sponsor
Vestre Viken Hospital Trust
Enrollment
300
Locations
1
Primary Endpoint
Attended follow-up visits in primary healthcare
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 3, 2025
End Date
December 20, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Attended follow-up visits in primary healthcare

Time Frame: 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

Time Frame: 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 Outcomes

  • Change in the SMART2 risk score(From baseline to weeks 26 and 52)
  • Changes in lipid profile(From baseline to weeks 26 and 52)
  • Changes in systolic blood pressure(From baseline to weeks 26 and 52)
  • Changes in HbA1c(From baseline to weeks 26 and 52)
  • Changes in smoking status(From baseline to weeks 26 and 52)

Study Sites (1)

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