Digital Support Program for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLinkoeping University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Barriers to participation (e.g., not Swedish-speaking, cognitive impairment, severe mental illness, substance abuse)
Life expectancy of less than six months
Trial design
Design model
Parallel
Treatments tested in this trial
Tailored implementation support
Other interventionTailored implementation support
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Tailored implementationExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Perceived control attitudes
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.
Time frame
At enrollment and at the end of the intervention at 6 monthSecondary outcomes
1
Self-care
Measured using the European Heart Failure Self-care Behaviour Scale. The scale has 9 item. The possible range for the total score is from 0 to 100. Higher scores reflect greater levels of self-care.
Time frame
At enrollment and at the end of the intervention at 6 month2
Perceived control
Perceived Attitude Scale with 4 items. The possible range for the total score is from 4 to 28. Higher scores reflect higher levels of perceived control.
Time frame
At enrollment and at the end of the intervention at 6 month3
Heart failure knowledge
Heart failure knowledge scale has 3 parts. The first part has 15 knowledge questions and the possible range for the total is 0-15. Higher scores reflect greater levels of knowledge. The second part measures the trust the person with heart failure has in his/her knowledge with 3 items on a scale from 1-5 and the possible range for the total is 3-15. Higher scores reflect greater levels of trust.The third part measures perception of knowledge with 3 items on a scale from 1-5 and the possible range for the total is 3-15. Higher scores reflect greater levels of perceived knowledge.
Time frame
At enrollment and at the end of the intervention at 6 month4
Healthcare consumtion
Patient records of all health care consumption
Time frame
From enrollment to 12 month follow-upSponsors and contacts
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Source ClinicalTrials.gov