Effect and Cost-effectiveness of the Everyday Life Rehabilitation Intervention

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional
• Participants enrolled: 161
• From 15 Sept 2021 to the primary completion date, 30 Jun 2024
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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