Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06738381

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Vestre Viken Trust Drammen hospital

Drammen, Buskerud, Norway, 3014

Actively Recruiting

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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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