Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVestre Viken Hospital Trust

About this trial

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

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Digital intervention and motivational counselling

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Vestre Viken Hospital Trust

Lead sponsor

University of Oslo

Collaborator