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Recruiting NCT07275931

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

No phase Interventional Heart Failure With Reduced Ejection Fraction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tailored implementation support.
Who it may be relevant to
Registry conditions: Heart Failure With Reduced Ejection Fraction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Digital Support Program Via 1177 for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study for Evaluation of Effects and Implementation

Overview

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.

Detailed description

Will be added

Interventions

  • Other Tailored implementation support
    Tailored implementation support

Primary outcome measures

  • Perceived control attitudes [Time frame: At enrollment and at the end of the intervention at 6 month]
Secondary outcome measures (9)
  • Self-care [Time frame: At enrollment and at the end of the intervention at 6 month]
  • Perceived control [Time frame: At enrollment and at the end of the intervention at 6 month]
  • Heart failure knowledge [Time frame: At enrollment and at the end of the intervention at 6 month]
  • Healthcare consumtion [Time frame: From enrollment to 12 month follow-up]
  • Health related quality of life [Time frame: At enrollment and at the end of the intervention at 6 month]
  • Disease specific health-related quality of life [Time frame: At enrollment and at the end of the intervention at 6 month]
  • Symptoms of Depression [Time frame: At enrollment and at the end of the intervention at 6 month]
  • Continuity of care [Time frame: At enrollment and at the end of the intervention at 6 month]
  • Electronic Health Literacy [Time frame: At enrollment and at the end of the intervention at 6 month]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Sweden · 1 center
  • Linköping University Hospital — Linköping

Identifiers

NCT: NCT07275931 · 2023-04289-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗