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

NCT06573242 | Recruiting

• 1 other identifier: H-24031772
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Heart Failure

Keywords

rehabilitation

Outcome Measures

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).

  12 weeks

Secondary Outcomes (6)

• EQ-5D-5L

  12 weeks

• Hospital Anxiety and Depression Scale (HADS)

  12 weeks

• The European Heart Failure Self-care Behaviour Scale (EHFScB)

  12 weeks

• Kansas City cardiomyopathy questionnaire (KCCQ)

  12 weeks

• Caregiver contribution to HF self-management

  12 weeks

Study Arms (1)

DK:REACH-HF

EXPERIMENTAL

12 weeks of homebased cardiac rehabilitation for patients with heart failure and their caregivers

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

Interventions

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

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

DK:REACH-HF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (2)

Herlev and Gentofte HUniversity Hospital

Herlev, copenhagen, 2730, Denmark

RECRUITING

Herlev and Gentofte University Hospital

Herlev, Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Signe Stelling Stelling Risom, senior researcher

CONTACT

+4538686431; signe.stelling.risom@regionh.dk

Malene Hammer Hansen, Master degree

CONTACT

malene.hammer.hansen.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 27, 2024
• Study Start: August 8, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 20, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

DK (2)