Home-based Cardiac Rehabilitation for People Living With Heart Failure and Their Caregivers- The DK:REACH-HF Pilot Study

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHerlev and Gentofte Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Home-based cardiac rehabilitation for people living with Heart Failure and their caregivers

    Other intervention

    Intervention DK:REACH-HF is a home-based 12-week CR program for people living with HF and their caregivers.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: DK:REACH-HFExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
12 weeks

Secondary outcomes

1

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.

Time frame
12 weeks
2

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

Time frame
12 weeks
3

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

Time frame
12 weeks
4

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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