Digital support program for people with reduced ejection fraction heart failure
Digital Support Program Via 1177 for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study for Evaluation of Effects and Implementation
This study will test a digital support program to help adults with reduced ejection fraction heart failure manage their condition and feel more in control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Linkoeping University Government |
| Locations | 1 site (Linköping, Östergötland County) |
| Trial ID | NCT07275931 on ClinicalTrials.gov |
What this trial studies
This is a cluster-randomized controlled trial testing a tailored digital support program for patients with heart failure with reduced or midrange reduced ejection fraction, alongside a comparison of implementation strategies using RE-AIM, PRISM and ERIC frameworks. The primary outcome is patients' perceived control measured by the Control Attitude Scale, with secondary outcomes including health-related quality of life, self-care behaviors, heart failure knowledge, perceived continuity and participation in care, and depressive symptoms. Eligible participants are adults with an ejection fraction ≤50% verified by echocardiography or MRI, who can use BankID and a smartphone, tablet, or computer and understand Swedish. The trial is led by Linköping University and conducted at Linköping University Hospital with tailored implementation support delivered to participating clinics.
Who should consider this trial
Good fit: Adults (≥18) with HFrEF or HFmrEF (ejection fraction ≤50%) confirmed by imaging, who can read Swedish, use BankID and a smartphone/tablet/computer, and provide informed consent are ideal candidates.
Not a fit: Patients who are not Swedish-speaking, have significant cognitive impairment, severe mental illness, substance abuse, a life expectancy under six months, or no access to BankID or a compatible device are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the program could help patients feel more in control of their heart failure, improve self-care and quality of life, and reduce depressive symptoms.
How similar studies have performed: Previous digital self-management programs for heart failure have shown improvements in self-care and quality of life in some trials, though implementation outcomes and effectiveness have varied across settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Diagnosed with heart failure with reduced ejection fraction (HFrEF) or heart failure with midrange reduced ejection fraction (HFmrEF) (ejection fraction ≤50%) verified by echocardiography or Magnetic Resonance Imaging * Access to BankID, a computer, tablet, or smartphone * Aged ≥18 years * Able to understand and communicate in Swedish * Provided informed consent Exclusion criteria: * Barriers to participation (e.g., not Swedish-speaking, cognitive impairment, severe mental illness, substance abuse) * Life expectancy of less than six months
Where this trial is running
Linköping, Östergötland County
- Linköping University Hospital — Linköping, Östergötland County, Sweden (Recruiting)
Study contacts
- Principal investigator: Anna Stroemberg — Linkoeping University
- Study coordinator: Anna Stroemberg, Professor
- Email: anna.stromberg@liu.se
- Phone: +46736569265
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.