Digital Support Program for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study
Recruiting · NCT07275931 · Interventional (participants receive a specific treatment) · Lead sponsor: Linkoeping University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed.
- Linköping University Hospital - Linköping, Östergötland County, Sweden