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