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Study identifier: NCT07275931 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Digital Support Program for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study

Condition: Heart Failure With Reduced Ejection Fraction  ·  Sponsor: Linkoeping University

PhaseNA
Planned participants240
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 i…

This description comes directly from the study's public registry record.

Talk to the study team

Anna Stroemberg, Professor  ·  +46736569265  ·  anna.stromberg@liu.se

Always discuss trial participation with your own doctor first.

Locations (1)

Linköping University HospitalLinköping, Östergötland County, SwedenRecruiting

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Source record: clinicaltrials.gov/study/NCT07275931