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临床试验/NCT05056415
NCT05056415招募中不适用

Effect and Cost-effectiveness of the 'Everyday Life Rehabilitation' Intervention: a Pragmatic RCT of Integrated, Recovery-focused Rehabilitation Within Sheltered and Supported Housing Facilities for People With Psychiatric Disabilities

Umeå University2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
2
主要终点
Change from baseline 'Recovering quality of life score' at 6 months

研究概览

简要总结

The person-centered, motivational, recovery-, and activity-based intervention model 'Everyday Life Rehabilitation´ (ELR), integrated in sheltered and supported housing facilities for people with severe psychiatric disabilities, has shown significant outcomes in feasibility studies, and thus a RCT is required, for the purpose of establishing the effectiveness and cost-effectiveness of ELR.

All municipalities in northern and middle Sweden will be invited. Residents who meet the inclusion criteria, will be invited to participate. Housing-units, with associated residents giving consent, will be randomized to either receive intervention with ELR plus treatment as usual (TAU), or TAU alone for control group. Hence, the present study is a cluster RCT. The control group will, after control-period, be offered ELR. Professionals involved in the ELR intervention group; that is occupational therapists, housing staff and housing managers, will receive an educational package. It is hypothesized that the intervention-group will improve in personal and social recovery as well as quality of life.

The primary outcome is recovering quality of life assessed by ReQoL, and secondary outcomes are self-perceived recovery, everyday functioning, and goal-attainment at 6 months, assessed using RAS-DS, and GAS, respectively. ReQoL will be transformed into QALY´s for calculation of cost-effectiveness.

The study has an adaptive design, including an internal pilot year one and two, in order to determine required sample sizes before continuing with the full scale RCT.

详细描述

The investigators intend to study the extent to which the intervention under study; the Everyday Life Rehabilitation (ELR), is an effective, and cost-effective model for co-planned rehabilitative services in sheltered and supported housing facilities, aiming at supporting residents´ personalized recovery pathway. The project is of high relevance with its permeating perspectives of severe psychiatric disability (SPD), equity, and quality improvement, in the intersection of health and social care in accommodations.

The ELR project is both user- and practice-oriented. The main focus is to study whether the ELR-model is effective, cost-effective, and relevant for users, based on pre-/post-intervention variables from a resident perspective, such as self-perceived recovery, quality of life, everyday functioning, and goal fulfilment of residents. The project is also practice-oriented with a web-based training, methods and tools for staff. The project is pragmatic in the sense of implementing and studying the ELR model in as natural context as possible. Throughout the investigators will collaborate with user- and relative associations, municipalities, and R&D units, in order to develop an intervention that is relevant and useful.

It has been shown that people with SPD and impaired autonomy have significantly poorer health than the general population, while at the same time they do not have access to equal health care, despite that they belong to the highest priority group according to the Swedish Parliament's principles for prioritization of healthcare. The high priority is based on the fact that the target group has low autonomy and does not speak out loudly for themselves, or can argue for their right to health care, further that they do not actively seek and demand health care, along with the magnitude of suffering, and the impact on life quality. There is a gap in knowledge, regulations, and lack of interventions suiting this context. Both rehabilitative healthcare interventions in practice, and RCT´s, are sparse regarding interventions for this target group living in sheltered or supported housing facilities. Thus, it is important to develop and test new potentially useful and effective interventions.

Therefore, a manualized but individually flexible model for integrated healthcare-rehabilitation in collaboration with housing staff in supported or sheltered housing facilities; the Everyday Life Rehabilitation (ELR), has been developed by the project manager (Lindström, 2007), and tested in feasibility studies (Lindström et al, 2011; 2011b; 2012; 2013; 2017), aiming at personal recovery and meaningful everyday activities for persons with SPD. The ELR development is thus based on five years of previous research with feasibility studies, and has shown significant impact on residents' everyday functioning and health, as well as the practices of professionals. Based on these feasibility studies, the original ELR has been slightly revised, adding a monthly follow-up by housing managers, and clarified tools for co-planning, in order to promote early involvement in enhancing strategies. The Medical Research Council (MRC) guidelines for complex interventions have been thoroughly applied in the development process, and next, evidence is needed for implementation, requiring randomized controlled trial (RCT)-studies. Therefore, the investigators want to expand the design, and go further with a cluster RCT built on a slightly revised manual of the ELR intervention, adding clarified focus on management, the tools for collaboration, and a cost-effectiveness perspective.

Overall aim and research questions:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change from baseline 'Recovering quality of life score' at 6 months

时间窗: Measurements will be conducted pre-, and post intervention-/control-period of six months

Recovering quality of life will be measured for RQ 1 and RQ 2 using the Recovering quality of life (ReQoL) (Keetharuth et al, 2018). ReQoL applies to the whole spectrum of mental health conditions, from common mental health disorders through to very severe ones. ReQoL are comprised of positive and negative worded items. Items cover areas of quality of life, shown to be important for service users: Activity (meaningful); Belonging and relationships; Choice, control and autonomy; Hope; Self-perception; Well-being; and Physical health. An increase of points on the ReQoL score denotes improvement. In ReQoL-20, the minimum score is 0 and the maximum is 80, where 0 indicates poorest quality of life and 80 indicates highest quality of life. Preference weights are available for the ReQoL to generate quality adjusted life years (QALYs).

次要结局

  • Change from baseline 'Total Recovery score' at 6 months(Measurements will be conducted pre-, and post intervention-/control-period of six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Lindstrom

Principal Investigator, Assistant professor

Umeå University

研究点 (2)

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