Digital Support Program Via 1177 for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study for Evaluation of Effects and Implementation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Perceived control attitudes
Study Overview
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.
Detailed Description
Will be added
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Tailored implementation
This arm will receive tailored implementation support.
Intervention: Tailored implementation support (Other)
Control
This group will receive standard implementation of the support program.
Outcomes
Primary Outcomes
Perceived control attitudes
Time Frame: At enrollment and at the end of the intervention at 6 month
Measured with The Control Attitudes Scale-Revised. The scale has 8 item. The possible range for the total score is from 8 to 40. Higher scores reflect greater levels of perceived control.
Secondary Outcomes
- Self-care(At enrollment and at the end of the intervention at 6 month)
- Perceived control(At enrollment and at the end of the intervention at 6 month)
- Heart failure knowledge(At enrollment and at the end of the intervention at 6 month)
- Healthcare consumtion(From enrollment to 12 month follow-up)
- Health related quality of life(At enrollment and at the end of the intervention at 6 month)
- Disease specific health-related quality of life(At enrollment and at the end of the intervention at 6 month)
- Symptoms of Depression(At enrollment and at the end of the intervention at 6 month)
- Continuity of care(At enrollment and at the end of the intervention at 6 month)
- Electronic Health Literacy(At enrollment and at the end of the intervention at 6 month)
Investigators
Anna Stroemberg
Professor
Linkoeping University