Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Digital support for preventing heart disease events

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

Run by Vestre Viken Hospital Trust · NCT06738381 · Data updated 2026-11-12

This study is testing if a digital support program and motivational counseling can help people who have been hospitalized for heart disease stick to their treatment and lower their risk of future heart problems.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorVestre Viken Hospital Trust
Academic / other
Locations1 site (Drammen, Buskerud)
StatusRecruiting
StartedFebruary 3, 2025
Main results expectedDecember 20, 2026
Study endsDecember 20, 2026
Registry record updatedFebruary 21, 2025
Trial IDNCT06738381 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older who have been hospitalized for an ASCVD event and have access to a smartphone or tablet.

Probably not a fit

Patients with significant cognitive impairments, severe mental health issues, or short life expectancy due to serious illnesses may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to reduce the risk of recurrent atherosclerotic cardiovascular disease (ASCVD) events by providing patients with a digital platform and motivational counseling after hospitalization. Participants will be randomly assigned to receive either standard care or enhanced care that includes a motivational counseling session and access to a digital intervention for six months. The study focuses on improving adherence to treatment and managing risk factors such as high cholesterol, blood pressure, and lifestyle choices. It is conducted at three secondary care hospitals in Norway.

Why it matters

Potential benefit: If successful, this approach could significantly lower the rates of hospital readmissions for patients with ASCVD.

How similar studies have gone: Other studies have shown promise in using digital interventions for chronic disease management, suggesting potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Vestre Viken Trust Drammen hospital
    Drammen, Buskerud, Norway
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.