NCT07275931 Digital Support Program for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study
| NCT ID | NCT07275931 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Linkoeping University |
| Condition | Heart Failure With Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2025-12-15 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Anna Stroemberg
PRINCIPAL INVESTIGATOR
Linkoeping University
Frequently Asked Questions
Who can join the NCT07275931 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07275931 currently recruiting?
Yes, NCT07275931 is actively recruiting participants. Contact the research team at anna.stromberg@liu.se for enrollment information.
Where is the NCT07275931 trial being conducted?
This trial is being conducted at Linköping, Sweden.
Who is sponsoring the NCT07275931 clinical trial?
NCT07275931 is sponsored by Linkoeping University. The principal investigator is Anna Stroemberg at Linkoeping University. The trial plans to enroll 240 participants.
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