跳至主要内容
临床试验/NCT06573242
NCT06573242招募中不适用

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

Herlev and Gentofte Hospital4 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
75
试验地点
4
主要终点
Minnesota Living with Heart Failure questionnaire

研究概览

简要总结

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.

详细描述

Globally, Heart Failure (HF) is a common and severe disease affecting millions of people and a major driver of poor health-related quality of life (HRQoL), increased risk of hospitalization and high healthcare costs. Due to the aging of the population as well as the improvements of life-prolonging cardiovascular invasive and medical treatments, the prevalence of patients living with HF is increasing and as many as 1 in 5 people are expected to develop HF during their lifetime. Cardiac rehabilitation (CR) for people living with HF has been demonstrated to be clinically efficacious and cost-effective by improving HRQoL and reducing the risk of hospital readmission. Guidelines therefore strongly recommend CR for people living with HF. However, the uptake and provision of CR for people with HF in Denmark is suboptimal with only 51 % of HF patients participating. Furthermore, there is evidence of social inequality in both referral and participation rates. Reasons for low uptake are complex, but a major barrier is that traditional mode of CR provision is center based. Barriers to center-based programs for patients include travel time and costs and dislike of group sessions. A key potential solution is therefore greater use of alternative modes of CR delivery.

Developed in the UK, 'Rehabilitation EnAblement in CHronic Heart Failure' REACH-HF is an evidence- and theory-based, patient-centred self-care home-based support program co-developed with patients, caregivers, and clinicians to meet the above challenges. Evaluated in the multicenter randomized controlled trial, participation in the REACH-HF programme has shown improved HRQoL for patients with HF and to be cost-effective in a UK healthcare setting. Furthermore, caregivers increased their confidence in the caregiver role. The REACH-HF is now being rolled out routinely across the UK National Health Service, improving CR access for people with HF and their caregivers. Including the core components of comprehensive CR, the REACH-HF program aligns with Danish guidelines. As part of the DK:REACH-HF project, the REACH-HF program and its materials have been translated and adapted into a Danish context. This adaptation process included the consideration of contextual differences between the healthcare systems, legislation, and culture of UK and Denmark and was informed by interviews with leaders and experts in cardiology, healthcare professionals working with HF in both hospital and municipality settings, as well as caregivers and patients. Following this evidence-based approach, the DK:REACH-HF is now ready to be assessed for its feasibility and acceptability to inform wider implementation for Danish patients with HF and their caregivers.

To investigate the feasibility of the DK:REACH-HF program the investigators will employ a single-arm, pre-post mixed methods design with a parallel process evaluation across two-three sites in Denmark. This will involve hospital centers and where applicable local municipalities where the DK:REACH-HF program will be delivered as an alternative to usual care.

The investigators intend to recruit a total of 75 HF patients and their caregivers where applicable, who will each receive the DK:REACH-HF programme delivered by a team of one or two trained intervention-facilitators.

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Minnesota Living with Heart Failure questionnaire

时间窗: 12 weeks

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).

次要结局

  • Caregiver contribution to HF self-management(12 weeks)
  • Kansas City cardiomyopathy questionnaire (KCCQ)(12 weeks)
  • The European Heart Failure Self-care Behaviour Scale (EHFScB)(12 weeks)
  • Caregiver burden scale(12 weeks)
  • EQ-5D-5L(12 weeks)
  • Hospital Anxiety and Depression Scale (HADS)(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Signe Stelling Risom

Senior researcher

Herlev and Gentofte Hospital

研究点 (4)

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