背景:患有严重精神残疾和自主性受损的人,住在有庇护或支持的住房设施中,经常导致久坐不动,独自生活在室内,健康状况明显低于人口中的其他人。有意义的日常活动对于恢复富裕很重要,agentic,社会,充满希望的日常生活。日常生活康复(ELR)模型-以人为中心的活动和以恢复为导向的干预-在可行性研究中显示出积极的结果,因此,需要一项随机对照试验(RCT)来确定ELR的有效性,以及成本效益的计算。
方法:ELR-RCT是一种务实的,双臂平行集群RCT评估使用ELR的效果和成本效益从两个测量点超过6个月(干预前)和3年内的三波。主要结果是在6个月时恢复生活质量(ReQoL),次要结局是6个月时的自我感知恢复和日常功能(RAS-DS)。此外,目标达成量缩放(GAS)将用于干预组。已对主要结果测量进行了功效分析。第一波将包括一名内部飞行员,6个月后进行评估,在第二波和第三波中继续进行全尺寸RCT之前,用作决定更新所需样本量和任何其他适应需求的基础。瑞典北部地理区域内的所有城市,为患有严重精神或神经精神残疾的人提供至少一个庇护或支持的住房设施,包括获得职业治疗,将被注册。参与者将被随机分组,以接受ELR加照常治疗(TAU)或单独的TAU进行控制期。对照组此后将接受延迟的ELR。职业治疗师和住房工作人员将获得教育套餐,手册,和工具,以及在干预期间与同事的反思。住房经理将收到每月跟进和与员工指导的问题。
结论:这是一项在庇护或支持的住房设施中使用ELR干预模型的首次RCT研究的内部试点和全面试验的方案,评估效果和成本效益。
背景:ClinicalTrials.govNCT05056415。2021年9月24日注册。
BACKGROUND: People with severe psychiatric disabilities and impaired autonomy, living in sheltered or supported housing facilities, often lead sedentary, solitary lives indoors and have significantly poorer health than others in the population. Meaningful everyday activities are important for the recovery towards an enrichening, agentic, social, and hopeful everyday life. The Everyday Life Rehabilitation (ELR) model-a person-centred activity- and recovery-oriented intervention-has shown positive outcomes in feasibility studies, and thus a randomised controlled
trial (RCT) is required to establish the effectiveness of ELR, along with calculations of cost-effectiveness.
METHODS: The ELR-RCT is a pragmatic, two-parallel-armed cluster RCT evaluating the effect and cost-effectiveness of using ELR from two measurement points over 6 months (pre-post intervention) and in three waves over 3 years. The primary outcome is recovering quality of life (ReQoL) at 6 months, and the secondary outcome is self-perceived recovery and daily functioning (RAS-DS) at 6 months. Additionally, Goal Attainment Scaling (GAS) will be used for the intervention group. Power analysis has been conducted for primary outcome measure. The first wave will include an internal pilot, to be evaluated after 6 months, used as basis for decisions on updating the required sample size and any other need for adaptations before continuing with the full-scale RCT in the second and third wave. All municipalities within a geographic area in northern Sweden, with a minimum of one sheltered or supported housing facility for people with severe psychiatric or neuropsychiatric disability, including access to occupational therapy, will be enrolled. Participants will be block-randomised to receive ELR plus treatment as usual (TAU) or TAU alone for a control period. The control group will thereafter receive delayed ELR. Occupational therapists and housing staff will receive an educational package, manuals, and tools, as well as reflections with colleagues during the intervention period. Housing managers will receive questions for monthly follow-up and coaching with staff.
CONCLUSIONS: This is a protocol for both an internal pilot and full
trial of the first RCT
study using the ELR intervention model in sheltered or supported housing facilities, evaluating the effects together with cost-effectiveness.
BACKGROUND: ClinicalTrials.gov NCT05056415. Registered on 24 September 2021.