A Reablement Intervention in Residential Aged Care (Re-RAC): Study Protocol for a Multi-center, Pragmatic Randomized Controlled, Open-label Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change in occupational performance related to the prioritized activity, measured with the COPM-P
研究概览
简要总结
Background: The global increase in older adults presents challenges for maintaining health and autonomy in residential aged care (RAC) facilities, where passivity has been shown to often diminish quality of life. However, the reablement approach, which enhances independence through personalized, multidisciplinary strategies, shows promise for addressing these issues and requires further evaluation, particularly in Swedish contexts.
The research project Reablement in RAC (Re-RAC) aims to evaluate the impact of the Re-RAC intervention on activity performance and satisfaction, participation, quality of life and well-being, and health economic outcomes for older adults in RAC facilities, while also describe participant and staff experiences.
Methods: This study is a multi-center prospective pragmatic randomized controlled trial with two parallel groups that will evaluate the Re-RAC intervention compared to treatment as usual, using quantitative, qualitative and health economic methods.
The Re-RAC intervention begins with an interview according to Canadian Occupational Performance Measure (COPM) to identify a meaningful goal, followed by a personalized support plan with training activities, supported by nursing staff. The intervention lasts 8 weeks, with adjustments made based on progress, and ends with a COPM reassessment of the participant's performance and satisfaction. Eighty-six participants will be included, assessed for performance (COPM-performance), satisfaction (COPM-satisfaction), health-related quality of life (EQ-5D-5L), psychological well-being (WHO-5), and physical activity levels (measured by an accelerometer), before and after the intervention. Pain will also be assessed for potential associations with other outcomes. Participants' and staff's experiences will be described through interviews, and cost-effectiveness will be evaluated by calculating the cost per quality adjusted life-years gained.
Discussion: The Re-RAC project evaluates the impact of a reablement intervention on activity performance, satisfaction, quality of life, well-being, and health outcomes for older adults in RAC facilities through a pragmatic randomized controlled trial, with assessments before and after the 8-week intervention. The study also explores participant and staff experiences and evaluates cost-effectiveness. The results of this study will offer valuable insights to inform the future implementation and assessment of reablement interventions in RAC settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older adults aged 65 years and above, residing in a somatic ward at one of the RAC facilities where the study will be conducted, and meeting the inclusion criteria, are eligible to participate in the study. The inclusion criteria require that the older adult must be able to engage in conversations in Swedish and be able to participate in both the assessments and the intervention.
排除标准
- •Persons having severe cognitive impairment (≤17) according to Mini Mental State Examination-Swedish version (MMSE-SR; screening for cognitive function) or being very severely frail or terminally ill according to Clinical Frailty Scale (≥8) (CFS-9) will be excluded.
结局指标
主要结局
Change in occupational performance related to the prioritized activity, measured with the COPM-P
时间窗: From enrollment to the end of treament after 8 weeks
The COPM is an interview-administered instrument used to assess occupational performance (COPM-P) and satisfaction with performance (COPM-S) for up to five self-determined activity issues in the areas of self-care, productivity, and leisure. Participants will rate their performance and satisfaction with their highest-priority activity on a scale of 1-10, where 1 = unable to perform at all/not satisfied at all, and 10 = able to perform extremely well/extremely satisfied.
次要结局
未报告次要终点
研究者
Kajsa Lidström Holmqvist
Associate professor
Örebro University, Sweden