Actively Recruiting
Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease
Led by Vestre Viken Hospital Trust · Updated on 2025-02-21
300
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
Sponsors
V
Vestre Viken Hospital Trust
Lead Sponsor
U
University of Oslo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older and able to give informed consent and cooperate
- Hospitalized with a planned or unplanned ASCVD event or have established atherosclerosis
- Have access to a smartphone or tablet
You will not qualify if you...
- Any condition or situation that may pose significant risk, interfere with participation, or make informed consent impossible, including cognitive impairment, seizure disorders, active suicidal intent, substance or alcohol dependence, psychotic disease, major depression or bipolar disorders, concurrent psychological treatments, and ongoing night shift work
- Short life expectancy less than 12 months due to end-organ or malignant diseases
- Clinically significant anxiety or depression symptoms (HADS A and/or HADS-D score ≥8)
- Unable to understand Norwegian
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vestre Viken Trust Drammen hospital
Drammen, Buskerud, Norway, 3014
Actively Recruiting
Research Team
J
John Munkhaugen, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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