Department of Community Medicine and Rehabilitation, Umeå University, 901 87, Umeå, Sweden.
Department of Epidemiology and Global Health, Umeå University, Umeå, Sweden.
Trials. 2022 Aug 15;23(1):657. doi: 10.1186/s13063-022-06622-0.
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.
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.
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.
ClinicalTrials.gov NCT05056415. Registered on 24 September 2021.
生活在庇护或支持性住房设施中的严重精神残疾和自主能力受损的人，往往在室内过着久坐、孤独的生活，健康状况明显不如其他人群。有意义的日常活动对于恢复充实、自主、社交和充满希望的日常生活非常重要。日常生活康复（ELR）模式是一种以人为中心的活动和以康复为导向的干预措施，在可行性研究中显示出积极的结果，因此需要进行随机对照试验（RCT）来确定 ELR 的有效性，并计算成本效益。
ELR-RCT 是一项实用的、两平行臂的集群 RCT，评估使用 ELR 在 6 个月（干预前后）的两个测量点和 3 年内的三个波次的效果和成本效益。主要结局是 6 个月时的恢复生活质量（ReQoL），次要结局是 6 个月时的自我感知康复和日常功能（RAS-DS）。此外，目标实现量表（GAS）将用于干预组。已对主要结局测量进行了功率分析。第一波将包括一个内部试点，在 6 个月后进行评估，作为决定是否更新所需样本量和在第二波和第三波继续进行全规模 RCT 之前进行任何其他调整的基础。瑞典北部一个地理区域内的所有市都将被纳入，该区域内至少有一个为严重精神或神经精神残疾人士提供的庇护或支持性住房设施，包括获得职业治疗的机会。参与者将按块随机分配接受 ELR 加常规治疗（TAU）或 TAU 作为对照期的单独治疗。对照组将随后接受延迟的 ELR。职业治疗师和住房工作人员将在干预期间接受教育包、手册和工具，以及与同事进行反思。住房经理将收到每月随访和与员工指导的问题。
这是一项在庇护或支持性住房设施中使用 ELR 干预模式的首次 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。
ClinicalTrials.gov NCT05056415。于 2021 年 9 月 24 日注册。
