Effect and Cost-effectiveness of the Everyday Life Rehabilitation Intervention

NCT05056415 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2024-09-19

No results posted yet for this study

Summary

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.

Conditions

  • Psychiatric or Mood Diseases or Conditions
  • Neuropsychiatric Syndrome
  • Psychosis
  • Autism
  • Severe Mental Disorder

Interventions

OTHER

Everyday Life Rehabilitation (ELR)

Everyday Life Rehabilitation (ELR) is an intervention model for integrated occupational therapy in close collaboration with housing staff in sheltered and supported housing facilities (Lindström, 2007; 2011), aiming at personal recovery and engagement in meaningful everyday activities for persons with SPD. The mediators are: personcentred, motivational, recovery- and activity-based methods, negotiation of user goal priority and expected outcome; methods for training in real-life situations; devices for collaboration; support from staff on an everyday basis; and an educational package including web-sections, manuals, and collegiate tutorial. The language and actions of professionals promote hope, self-discovery and shared-decision making, shaped in partnership with residents. The resident is also encouraged to access different resources outside of health and social care such as family, peer and social support, out-of-housing strategies, and sources in the open society.

OTHER

Treatment as usual (TAU)

No standardized instructions about the efforts is given to staff at the accommodations. Usually, only short terms efforts are offered to residents, such as prescribing technical aids.

Sponsors & Collaborators

  • Swedish Council for Working Life and Social Research

    collaborator OTHER
  • Umeå University

    lead OTHER

Principal Investigators

  • Maria Lindström, PhD · Umeå university, Dept of Community Medicine and Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05056415 on ClinicalTrials.gov