住宅老年护理(Re-RAC):一项多中心实用随机对照开放标签试验的研究方案。

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Trials Pub Date : 2025-08-18 DOI:10.1186/s13063-025-08999-0
Anna Philipson, Mialinn Arvidsson Lindvall, Cecilia Pettersson, Lena Strålman, Kajsa Lidström Holmqvist
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引用次数: 0

摘要

背景:居住在住宅养老设施(RAC)可以钝化和负面影响居民的福祉和生活质量。随着全球老年人口的不断增长,越来越多的人居住在RAC设施中,解决这些问题至关重要。以人为本的康复通过量身定制的多学科战略加强活动和参与,在家庭环境中显示出令人鼓舞的结果。但是,它在RAC设施中的执行情况,特别是在瑞典,需要进一步评价。本研究项目将探讨RAC (Re-RAC)的康复干预是否会影响居住在RAC设施中的老年人的活动表现和满意度、参与、生活质量和幸福感。此外,该项目将评估干预措施的健康经济影响,并探索与结果的潜在关联。进一步的目的是描述参与Re-RAC的老年人和RAC设施工作人员的经验。方法:这是一项多中心前瞻性实用随机对照试验,有两个平行组,将Re-RAC干预与常规护理进行比较。计划共招募86名参与者。将使用定量、定性和健康经济学方法对8周干预进行评估。数据将在基线和干预后收集。还将收集干预前后3个月的卫生经济数据。主要结果是使用加拿大职业绩效量表捕获的活动绩效和绩效满意度;次要结果,即健康相关的生活质量、心理健康和身体活动水平也将被评估。参与者和工作人员的经验将通过个人和焦点小组访谈获得。成本效益将通过计算每个获得的质量调整寿命年的成本来估计。定量数据将使用描述性和比较统计进行分析;定性数据将使用专题分析和焦点小组方法进行分析。讨论:本研究通过一项现实世界的实用试验来评估RAC中老年人的Re-RAC干预措施,检查RAC设施中老年人的活动表现、满意度、生活质量、幸福感和健康结果。该研究还探讨了参与者和工作人员的经验,并评估了成本效益。研究结果将为RAC环境下的治疗干预措施的未来实施和评估提供有价值的见解。试验注册:ClinicalTrials.gov, ID: NCT06793501。于2025年1月20日注册。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Reablement in Residential Aged Care (Re-RAC): study protocol for a multi-center pragmatic randomized controlled open-label trial.

Reablement in Residential Aged Care (Re-RAC): study protocol for a multi-center pragmatic randomized controlled open-label trial.

Background: Living in residential aged care (RAC) facilities can be passivating and negatively impact residents' well-being and quality of life. With a growing global population of older adults and an increasing number residing in RAC facilities, it is crucial to address these concerns. Person-centered reablement, which enhances activity and participation through tailored, multidisciplinary strategies, has shown promising results in home settings. However, its implementation in RAC facilities, especially in Sweden, requires further evaluation. This research project will examine whether the reablement intervention in RAC (Re-RAC) impacts activity performance and satisfaction, participation, quality of life, and well-being, in older adults living in RAC facilities. Additionally, the project will evaluate the health-economic effects of the intervention and explore potential associations with the outcomes. A further aim is to describe the experiences of both the participating older adults and RAC facility staff involved in Re-RAC.

Methods: This is a multi-center prospective pragmatic randomized controlled trial has two parallel groups comparing the Re-RAC intervention with usual care. A total of 86 participants are planned to be enrolled. The 8-week intervention will be evaluated using quantitative, qualitative, and health-economic methods. Data will be collected at baseline and after the intervention. Health-economic data will also be gathered 3 months before and after intervention. Primary outcomes are activity performance and satisfaction with performance captured using the Canadian Occupational Performance Measure; secondary outcomes, i.e., health-related quality of life, psychological well-being, and physical activity levels will also be evaluated. Experiences of participants and staff will be captured through individual and focus-group interviews. Cost-effectiveness will be estimated by calculating the cost per quality-adjusted life year gained. Quantitative data will be analyzed using descriptive and comparative statistics; qualitative data will be analyzed using thematic analysis and focus-group methodology.

Discussion: This study evaluates the Re-RAC intervention for older adults in RAC through a real-world pragmatic trial, examining activity performance, satisfaction, quality of life, well-being, and health outcomes for older adults in RAC facilities. The study also explores participant and staff experiences and evaluates cost-effectiveness. The results will offer valuable insights informing the future implementation and assessment of reablement interventions in RAC settings.

Trial registration: ClinicalTrials.gov, ID: NCT06793501 . Registered on 20 January 2025.

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来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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