农村阿巴拉契亚心力衰竭患者和家庭照护者的姑息治疗：一项随机对照试验。
Palliative care for patients with heart failure and family caregivers in rural Appalachia: a randomized controlled trial.
机构信息
West Virginia University School of Nursing, Morgantown, USA.
Department of Biostatistics School of Public Health, West Virginia University, Morgantown, USA.
出版信息
BMC Palliat Care. 2024 Aug 3;23(1):199. doi: 10.1186/s12904-024-01531-2.
BACKGROUND
Heart failure (HF) is a debilitating disease with worsening symptoms and family caregiving burden. HF affects more than 8 million Americans. West Virginia has the highest HF death rate in the U.S. and limited healthcare services. This study tested whether the family HF palliative and end-of-life care intervention (FamPALcare) improved patient and caregiver outcomes at 3- and 6-month study endpoints.
METHODS
This study used a randomized controlled trial design. Patients with HF and their caregivers were randomly assigned together to the intervention (n = 21) or control (n = 18) group. The intervention included five telephone coaching sessions on the HF home, palliative, and end-of-life care. The outcome data collected at baseline and at 3 and 6 months were from the patients' (a) HF-related health status and depression/anxiety scale scores; and from caregivers' (b) caregiving burden and depression/anxiety scale scores; and (c) anonymous ratings on the 11-item FamPALcare helpfulness scale, completed by the intervention participants.
RESULTS
The mean age of the patients was 65.66 (SD = 13.72) years, and 67% were White males. The mean age of the caregivers was 62.05 (SD = 13.14) years, and 77% were White females. Compared to the controls, patients in the intervention group had significantly greater scores for HF-related health status (p < .05) and lower depression/anxiety scores at 6 months, the study endpoint. The family caregivers in the intervention group had significantly lower scores on caregiving burden (p < .05) and depression/anxiety (p < .01) at 3 months. The mean helpfulness rating was M = 4.46 out of 5 (SD = 0.49).
CONCLUSIONS
The FamPALcare intervention was found to be effective at improving patient HF-related health status and reducing caregiver burden and improving both patient and caregiver depression and anxiety scores. The FamPALcare HF intervention was found feasible and consistently delivered (fidelity). The FamPALcare intervention's cost-effectiveness and helpfulness ratings information will be used to plan for subsequent clinical trials.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04153890, Registered on 4 November 2019, https://clinicaltrials.gov/ct2/show/NCT04153890 .
背景
心力衰竭（HF）是一种使人虚弱的疾病，其症状会逐渐恶化，家庭护理负担也会加重。HF 影响了超过 800 万的美国人。西弗吉尼亚州的 HF 死亡率是美国最高的，且医疗保健服务有限。本研究旨在测试家庭 HF 姑息治疗和临终关怀干预（FamPALcare）是否能改善患者和护理人员在 3 个月和 6 个月的研究终点时的结果。
方法
本研究采用随机对照试验设计。HF 患者及其护理人员被随机分为干预组（n=21）和对照组（n=18）。干预包括五次关于 HF 家庭、姑息治疗和临终关怀的电话辅导课程。基线和 3 个月和 6 个月收集的结局数据来自患者的（a）HF 相关健康状况和抑郁/焦虑量表评分；以及护理人员的（b）护理负担和抑郁/焦虑量表评分；以及（c）干预参与者对 11 项 FamPALcare 有用性量表的匿名评分。
结果
患者的平均年龄为 65.66（SD=13.72）岁，67%为白人男性。护理人员的平均年龄为 62.05（SD=13.14）岁，77%为白人女性。与对照组相比，干预组患者在 6 个月（研究终点）时的 HF 相关健康状况评分显著更高（p<.05），抑郁/焦虑评分显著更低。干预组的家庭护理人员在 3 个月时的护理负担（p<.05）和抑郁/焦虑评分（p<.01）显著更低。有用性评分的平均值为 M=4.46 分（SD=0.49 分）。
结论
FamPALcare 干预措施被发现能有效改善患者 HF 相关健康状况，减轻护理人员负担，并改善患者和护理人员的抑郁和焦虑评分。FamPALcare HF 干预措施被发现是可行的，并且能够持续实施（保真度）。FamPALcare 干预措施的成本效益和有用性评分信息将用于计划后续的临床试验。
试验注册
ClinicalTrials.gov NCT04153890，于 2019 年 11 月 4 日注册，https://clinicaltrials.gov/ct2/show/NCT04153890。
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