对射血分数保留的心力衰竭患者及其照顾者进行的一项基于家庭的康复随机试点试验与常规护理的过程评估。
Process evaluation of a randomised pilot trial of home-based rehabilitation compared to usual care in patients with heart failure with preserved ejection fraction and their caregiver's.
作者信息
Smith Karen, Lang Chim, Wingham Jennifer, Frost Julia, Greaves Colin, Abraham Charles, Warren Fiona C, Coyle Joanne, Jolly Kate, Miles Jackie, Paul Kevin, Doherty Patrick J, Davies Russell, Dalal Hasnain, Taylor Rod S
机构信息
School of Nursing and Health Sciences, University of Dundee & NHS Tayside, Dundee, UK.
School of Medicine, University of Dundee & NHS Tayside, Dundee, UK.
出版信息
Pilot Feasibility Stud. 2021 Jan 6;7(1):11. doi: 10.1186/s40814-020-00747-2.
BACKGROUND
Whilst almost 50% of heart failure (HF) patients have preserved ejection fraction (HFpEF), evidence-based treatment options for this patient group remain limited. However, there is growing evidence of the potential value of exercise-based cardiac rehabilitation. This study reports the process evaluation of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention for HFpEF patients and their caregivers conducted as part of the REACH-HFpEF pilot trial.
METHODS
Process evaluation sub-study parallels to a single-centre (Tayside, Scotland) randomised controlled pilot trial with qualitative assessment of both intervention fidelity delivery and HFpEF patients' and caregivers' experiences. The REACH-HF intervention consisted of self-help manual for patients and caregivers, facilitated over 12 weeks by trained healthcare professionals. Interviews were conducted following completion of intervention in a purposeful sample of 15 HFpEF patients and seven caregivers.
RESULTS
Qualitative information from the facilitator interactions and interviews identified three key themes for patients and caregivers: (1) understanding their condition, (2) emotional consequences of HF, and (3) responses to the REACH-HF intervention. Fidelity analysis found the interventions to be delivered adequately with scope for improvement in caregiver engagement. The differing professional backgrounds of REACH-HF facilitators in this study demonstrate the possibility of delivery of the intervention by healthcare staff with expertise in HF, cardiac rehabilitation, or both.
CONCLUSIONS
The REACH-HF home-based facilitated intervention for HFpEF appears to be a feasible and a well-accepted model for the delivery of rehabilitation, with the potential to address key unmet needs of patients and their caregivers who are often excluded from HF and current cardiac rehabilitation programmes. Results of this study will inform a recently funded full multicentre randomised clinical trial.
TRIAL REGISTRATION
ISRCTN78539530 (date of registration 7 July 2015).
背景
虽然近50%的心力衰竭（HF）患者射血分数保留（HFpEF），但针对该患者群体的循证治疗选择仍然有限。然而，越来越多的证据表明基于运动的心脏康复具有潜在价值。本研究报告了作为REACH-HFpEF试点试验一部分，针对HFpEF患者及其护理人员的慢性心力衰竭康复促进（REACH-HF）干预的过程评估。
方法
过程评估子研究与单中心（苏格兰泰赛德）随机对照试点试验并行，对干预保真度实施以及HFpEF患者和护理人员的体验进行定性评估。REACH-HF干预包括为患者和护理人员提供自助手册，由经过培训的医护人员在12周内提供协助。在干预完成后，对15名HFpEF患者和7名护理人员的目标样本进行了访谈。
结果
来自促进者互动和访谈的定性信息确定了患者和护理人员的三个关键主题：（1）了解他们的病情，（2）HF的情感后果，以及（3）对REACH-HF干预的反应。保真度分析发现干预措施得到了充分实施，但在护理人员参与度方面仍有改进空间。本研究中REACH-HF促进者不同的专业背景表明，具有HF、心脏康复或两者专业知识的医护人员有可能实施该干预。
结论
针对HFpEF的基于家庭的REACH-HF促进干预似乎是一种可行且被广泛接受的康复模式，有可能满足患者及其护理人员的关键未满足需求，这些患者和护理人员通常被排除在HF和当前心脏康复计划之外。本研究结果将为最近资助的一项全面的多中心随机临床试验提供信息。
试验注册
ISRCTN78539530（注册日期2015年7月7日）。
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