NCT07275931Recruiting
Digital Support Program for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study
Digital Support Program Via 1177 for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study for Evaluation of Effects and Implementation
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
The overall aim of this project is to evaluate the effects of a digital support program for patients with heart failure through a cluster-randomized controlled trial, and to investigate the outcomes of different implementation strategies using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance), PRISM (Practical, Robust Implementation and Sustainability Model) and ERIC (Expert Recommendations for Implementing Change) framework. Our primary hypothesis is that the digital support program will improve patients' perceived control over their heart failure, measured with the validated Control Attitude Scale. Secondary hypotheses are that the program will increase patients' health-related quality of life, self-care behaviors, heart failure knowledge, perceived continuity of care, and participation in care, and reduce symptoms of depression. Implementation aim (based on the RE-AIM, PRISM and ERIC frameworks) The implementation component of the study aims to compare two different implementation strategies: a standard (basic) support package versus a tailored, context-specific support strategy. Heart failure clinics at hospitals an within primary care will be matched and randomized into two arms. The intervention arm will receive tailored implementation support to implement the support program. The control arm will recive implementation support according to a predefined standard procedure. Researchers will compare the intervention arm with control arm to see if there are any differences regarding the implementationsuccess between the arms. The patients in both arms will have access to the support program during six months.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 26 Nov 2025
- Start date
- 15 Dec 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Linkoeping University
- Diseases
- Heart failure
- NCT number
- NCT07275931
What you commit to
- Study type: Interventional
- Planned participants: 240
- From 15 Dec 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Barriers to participation (e.g., not Swedish-speaking, cognitive impairment, severe mental illness, substance abuse)
Other
- Life expectancy of less than six months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Linkoping University Hospital Coordinator of this site? Confirm its status | Linköping | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.