About this trial
Background: Participation in cardiac rehabilitation (CR) is a strong recommendation of clinical guidelines for the management of heart failure (HF) because it is demonstrated to be a clinically effective and cost-effective intervention. Despite this, Danish data shows the uptake of CR is suboptimal (51%). A major barrier is that the traditional mode of CR provision is centre based. Travelling (time and cost), dislike of group exercise, and inconvenient timings are some key problems to participation. A potential solution is use of home-based programmes as an alternative to traditional CR.
A novel home-based programme for patients with HF and their caregivers (REACH-HF), developed in the United Kingdom has achieved improvements in quality of life and proven to be cost effective. The REACH-HF program is translated and adapted into a Danish context (DK: REACH-HF) and is now ready to be tested in a Danish setting.
The aim of this project is to improve the access and uptake of CR among HF patients in Denmark, particularly in subgroups of patients who currently do not benefit from center-based CR.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged > 18 years
Confirmed diagnosis of Heart Failure (HF) with reduced Ejection Fraction (HFrEF) (Ejection Fraction (EF) <45%)
No worsening of HF symptoms within past 2 weeks resulting in hospitalization (to ensure stable patients)
Are deemed suitable for participating in Cardiac Rehabilitation (CR) by the outpatient HF clinic
Disqualifiers
Have undertaken CR within the past 12 months
Are unwilling/unable to travel to a rehabilitation center in the municipality or at the hospital
Are unable to understand the study information and/or corporate on giving informed consent
Trial design
Single group
Treatments tested in this trial
Home-based cardiac rehabilitation for people living with Heart Failure and their caregivers
Other interventionIntervention DK:REACH-HF is a home-based 12-week CR program for people living with HF and their caregivers.
Treatment groups
Trial outcomes
Primary outcomes
Minnesota Living with Heart Failure questionnaire
Questionnaire. The MLHFQ is a disease-specific questionnaire for patients with Heart failure, comprising 21 items rated on six-point Likert scales, represening, from 0 (none) to 5 (very much). It provides a total score (range 0-105) Higher scores means worse health related quality of life (HRQoL).
Secondary outcomes
EQ-5D-5L
Generic Health related quality of life. Questionnaire. comprises five dimensions, describing different aspect of health: mobility, self-care, usual activities, pain / discomfort and anxiety / depression. Each dimension has five response levels: (1) no problems,(2) slight problems, (3) moderate problems, (4) severe problems, (5) unable to/extreme. Higher scores means worse generic health related quality of life.
Hospital Anxiety and Depression Scale (HADS)
Questionnaire. Minimum Value: 0 Maximum Value: 21 (for each subscale: anxiety and depression; the total score can range from 0 to 42) Higher Scores Mean: Worse anxiety or depression. HADS assesses levels of anxiety and depression through separate subscales for each condition
The European Heart Failure Self-care Behaviour Scale (EHFScB)
Questionnaire: comprising 12 items rated on a 5-point scale between 1 (I completely agree) and 5 (I completely disagree). Higher score means worse heart failure self-care behaviour
Kansas City cardiomyopathy questionnaire (KCCQ)
Questionnaire. The KCCQ-12 is a 12-item questionnaire that measures physical function, symptoms, social function, and quality of life. Each Item responses are coded in sequential order (1, 2, 3, etc.) from the worst to the best status. Higher score means better status.
Sponsors and contacts
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