Study protocol for a pragmatic cluster RCT on the effect and cost-effectiveness of Everyday Life Rehabilitation versus treatment as usual for persons with severe psychiatric disability living in sheltered or supported housing facilities
Abstract 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 fo...
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ftdoajarticles:oai:doaj.org/article:f4c7d1d174f649e0b1047701c0530bdf 2023-05-15T17:45:12+02:00 Study protocol for a pragmatic cluster RCT on the effect and cost-effectiveness of Everyday Life Rehabilitation versus treatment as usual for persons with severe psychiatric disability living in sheltered or supported housing facilities Maria Lindström Lars Lindholm Per Liv 2022-08-01T00:00:00Z https://doi.org/10.1186/s13063-022-06622-0 https://doaj.org/article/f4c7d1d174f649e0b1047701c0530bdf EN eng BMC https://doi.org/10.1186/s13063-022-06622-0 https://doaj.org/toc/1745-6215 doi:10.1186/s13063-022-06622-0 1745-6215 https://doaj.org/article/f4c7d1d174f649e0b1047701c0530bdf Trials, Vol 23, Iss 1, Pp 1-15 (2022) ELR intervention Community-based mental health Severe mental illness Health equity Collaboration Occupational therapy Medicine (General) R5-920 article 2022 ftdoajarticles https://doi.org/10.1186/s13063-022-06622-0 2022-12-30T23:44:59Z Abstract 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 ... Article in Journal/Newspaper Northern Sweden Directory of Open Access Journals: DOAJ Articles Trials 23 1 |
institution |
Open Polar |
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Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
ELR intervention Community-based mental health Severe mental illness Health equity Collaboration Occupational therapy Medicine (General) R5-920 |
spellingShingle |
ELR intervention Community-based mental health Severe mental illness Health equity Collaboration Occupational therapy Medicine (General) R5-920 Maria Lindström Lars Lindholm Per Liv Study protocol for a pragmatic cluster RCT on the effect and cost-effectiveness of Everyday Life Rehabilitation versus treatment as usual for persons with severe psychiatric disability living in sheltered or supported housing facilities |
topic_facet |
ELR intervention Community-based mental health Severe mental illness Health equity Collaboration Occupational therapy Medicine (General) R5-920 |
description |
Abstract 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 ... |
format |
Article in Journal/Newspaper |
author |
Maria Lindström Lars Lindholm Per Liv |
author_facet |
Maria Lindström Lars Lindholm Per Liv |
author_sort |
Maria Lindström |
title |
Study protocol for a pragmatic cluster RCT on the effect and cost-effectiveness of Everyday Life Rehabilitation versus treatment as usual for persons with severe psychiatric disability living in sheltered or supported housing facilities |
title_short |
Study protocol for a pragmatic cluster RCT on the effect and cost-effectiveness of Everyday Life Rehabilitation versus treatment as usual for persons with severe psychiatric disability living in sheltered or supported housing facilities |
title_full |
Study protocol for a pragmatic cluster RCT on the effect and cost-effectiveness of Everyday Life Rehabilitation versus treatment as usual for persons with severe psychiatric disability living in sheltered or supported housing facilities |
title_fullStr |
Study protocol for a pragmatic cluster RCT on the effect and cost-effectiveness of Everyday Life Rehabilitation versus treatment as usual for persons with severe psychiatric disability living in sheltered or supported housing facilities |
title_full_unstemmed |
Study protocol for a pragmatic cluster RCT on the effect and cost-effectiveness of Everyday Life Rehabilitation versus treatment as usual for persons with severe psychiatric disability living in sheltered or supported housing facilities |
title_sort |
study protocol for a pragmatic cluster rct on the effect and cost-effectiveness of everyday life rehabilitation versus treatment as usual for persons with severe psychiatric disability living in sheltered or supported housing facilities |
publisher |
BMC |
publishDate |
2022 |
url |
https://doi.org/10.1186/s13063-022-06622-0 https://doaj.org/article/f4c7d1d174f649e0b1047701c0530bdf |
genre |
Northern Sweden |
genre_facet |
Northern Sweden |
op_source |
Trials, Vol 23, Iss 1, Pp 1-15 (2022) |
op_relation |
https://doi.org/10.1186/s13063-022-06622-0 https://doaj.org/toc/1745-6215 doi:10.1186/s13063-022-06622-0 1745-6215 https://doaj.org/article/f4c7d1d174f649e0b1047701c0530bdf |
op_doi |
https://doi.org/10.1186/s13063-022-06622-0 |
container_title |
Trials |
container_volume |
23 |
container_issue |
1 |
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1766148014952415232 |