Individually Tailored Digital Secondary Prevention After Hospitalization for Atherosclerotic Cardiovascular Disease: a Randomized Proof-of-concept Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Norway
Vestre Viken Trust Drammen hospital
RECRUITING
Drammen
Contact Information
Primary
John Munkhaugen, MD, PhD
johmun@vestreviken.no
+4797524194
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2026-12-20
Participants
Target number of participants: 300
Treatments
Experimental: Digital intervention and motivational counselling
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.
Active_comparator: Control group
Brief advices, tailored discharge information to patients and their general practitioners, and a nurse-led outpatient visit at six months follow-up
Sponsors
Collaborators: University of Oslo
Leads: Vestre Viken Hospital Trust

This content was sourced from clinicaltrials.gov