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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Digital intervention and motivational counselling
BehavioralA single sesstion of motivational interviewing and access to a digital plattform for a six months period
Treatment groups
Trial outcomes
Primary outcomes
Attended follow-up visits in primary healthcare
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
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
Between-group change in the validated SMART2 risk score
Changes in lipid profile
Between-group changes in total cholesterol, HDL-cholesterol and LDL-cholesterol in blood
Changes in systolic blood pressure
Between-group changes in systolic blood pressure
Changes in HbA1c
Between-group change in HbA1c levels in blood
Sponsors and contacts
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Vestre Viken Hospital Trust
Lead sponsor
University of Oslo
Collaborator