Digital support for preventing heart disease events
Individually Tailored Digital Secondary Prevention After Hospitalization for Atherosclerotic Cardiovascular Disease: a Randomized Proof-of-concept Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vestre Viken Hospital Trust Academic / other |
| Locations | 1 site (Drammen, Buskerud) |
| Trial ID | NCT06738381 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using digital interventions for chronic disease management, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Drammen, Buskerud
- Vestre Viken Trust Drammen hospital — Drammen, Buskerud, Norway (Recruiting)
Study contacts
- Study coordinator: John Munkhaugen, MD, PhD
- Email: johmun@vestreviken.no
- Phone: +4797524194
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.