Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease

Last updated: February 19, 2025
Sponsor: Vestre Viken Hospital Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atherosclerosis

Thrombosis

Coronary Artery Disease

Treatment

Digital intervention and motivational counselling

Clinical Study ID

NCT06738381
807276
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria (all the following):

  • Aged >=18 years and signed informed consent and expected cooperation according to ICH/GCP and national/local regulations

  • Hospitalised with an planned or unplanned ASCVD event and/or established atherosclerosis

  • Access to a smartphone or tablet

Exclusion criteria (any of the following):

-Any condition or situation, that in the investigator's opinion could put the subject at significant risk, confound the study results, interfere significantly with the subject participation in the study, or rendering informed consent unfeasible not limited to: cognitive impairment, seizure disorders, active suicidal intent or plans, substance or alcohol dependence, psychotic disease, major depressive disorders or bipolar disorders, receiving concurrent psychological treatments, and ongoing night shift work.

  • Short life expectancy (<12 months) due to end-organ (i.e COPD 4, CKD 4/5) or malignant diseases

  • Clinically significant symptoms of anxiety and depression (HADS A and/or HADS-D score ≥8)

  • Not being able to understand Norwegian.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Digital intervention and motivational counselling
Phase:
Study Start date:
February 03, 2025
Estimated Completion Date:
December 20, 2026

Connect with a study center

  • Vestre Viken Trust Drammen hospital

    Drammen, Buskerud 3014
    Norway

    Active - Recruiting

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