Home-based Cardiac Rehabilitation for People Living With Heart Failure and Their Caregivers- The DK:REACH-HF Pilot Study
NCT Number: NCT06573242
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure
Interventions: OTHER: Home-based cardiac rehabilitation for people living with Heart Failure and their caregivers
Sponsor: Herlev and Gentofte Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-08
Completion Date: 2026-07-01
Locations: Herlev and Gentofte University Hospital, Herlev, 2730, Denmark

Summary:
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.

Primary Outcome Measures: 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)., 12 weeks
Secondary Outcome Measures: 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., 12 weeks|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, 12 weeks|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, 12 weeks|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., 12 weeks|Caregiver contribution to HF self-management, Questionnaire. The caregiver contribution to self-care consist of 10 items devided into 3 scales and uses a 4-point Likert scale (neveror rarely, sometimes, frequently, always or daily). Higher scores means higher contribution to self-care, 12 weeks|Caregiver burden scale, Questionnaire. The Caregiver burden scale consist of 22 items devided into 5 scales and uses a 4 -point Likert scale rating from 1: "not at all" to 4: "very much". Higher scores means higher degree of burden., 12 weeks