RecruitingNot ApplicableNCT07275931

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


Sponsor

Linkoeping University

Enrollment

240 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Swedish study is testing whether a digital support program delivered via smartphone or computer can help people with heart failure better manage their condition, compared to usual care alone. **You may be eligible if...** - You have been diagnosed with heart failure where the heart pumps less effectively than normal (reduced or mid-range ejection fraction, confirmed by scan) - You are 18 or older - You can communicate in Swedish - You have access to a computer, tablet, or smartphone with BankID (Swedish digital ID) **You may NOT be eligible if...** - You have significant barriers to participation, such as cognitive impairment, severe mental illness, or substance abuse - You are not Swedish-speaking - Your life expectancy is less than 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTailored implementation support

Tailored implementation support


Locations(1)

Linköping University Hospital

Linköping, Östergötland County, Sweden

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NCT07275931


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