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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Digital intervention and motivational counselling

    Behavioral

    A single sesstion of motivational interviewing and access to a digital plattform for a six months period

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Digital intervention and motivational counsellingExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From baseline to weeks 6-8 and 26
2

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

Time frame
From baseline to weeks 6-8 and 26

Secondary outcomes

1

Change in the SMART2 risk score

Between-group change in the validated SMART2 risk score

Time frame
From baseline to weeks 26 and 52
2

Changes in lipid profile

Between-group changes in total cholesterol, HDL-cholesterol and LDL-cholesterol in blood

Time frame
From baseline to weeks 26 and 52
3

Changes in systolic blood pressure

Between-group changes in systolic blood pressure

Time frame
From baseline to weeks 26 and 52
4

Changes in HbA1c

Between-group change in HbA1c levels in blood

Time frame
From baseline to weeks 26 and 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vestre Viken Hospital Trust

Lead sponsor

University of Oslo

Collaborator