Effect and Cost-effectiveness of the Everyday Life Rehabilitation Intervention

NCT05056415 | Completed

• 1 other identifier: 330210302 - FORTE 2021-2024, M
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

RCT; effect; cost-effectiveness; equity; severe psychiatric disability; personcentered; personal recovery; Everyday Life Rehabilitation; Occupational Therapy

Outcome Measures

Primary Outcomes (1)

• Change from baseline 'Recovering quality of life score' at 6 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).

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

Secondary Outcomes (1)

• Change from baseline 'Total Recovery score' at 6 months

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

Other Outcomes (1)

• Goal Attainment at 6 months

  Goal attainment will be measured after an intervention-period of six months.

Study Arms (2)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

In the involved municipalities, TAU mainly consists of short-term efforts, such as Occupational Therapist (OT) prescribing technical aids, often initiated by the housing staff (HS). Daily support provided by HS varies, depending on the approach and commitment of individual staff and the norms that prevail in different housing units, as well as variations between municipalities. Co-planning on long-term rehabilitation efforts does not exist or is weak, and collaboration between OT and HS is, as described by staff from both parties, difficult to achieve. After a control-period of 6 month, house facilities within the TAU-group will also be offered ELR.

Other: Treatment as usual (TAU)

Everyday Life Rehabilitation (ELR) plus TAU

EXPERIMENTAL

ELR is a model for long-term, outreach, and personalized rehabilitation for persons with SPD living in sheltered or supported housing facilities, in close collaboration between resident, OT, and HS. ELR includes personcentred, motivational-, recovery- and activity-based methods, built on certain process steps. The focus is to promote personal recovery, while targeting meaningful daily activities, through person-driven goals, negotiated expectations, exploration and activity-training in real-life situations, and a maintenance phase. ELR includes a web-based educational package, and devices for reflective collaborative learning. ELR consists of a weekly session with an OT, followed by regular collaboration with HS, who support the resident on a daily basis, in line with guidance given by the OT and input shared from the HS. The intervention period will last for 6 months. Prior to the intervention, OT, HS, and HM will partake in web-based training, with associated manuals, and tools.

Other: Everyday Life Rehabilitation (ELR)

Interventions

Everyday Life Rehabilitation (ELR) OTHER

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.

Everyday Life Rehabilitation (ELR) plus TAU

Treatment as usual (TAU) OTHER

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.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults with severe psychiatric disability (SPD)
• living in sheltered or supported housing facility for people with SPD in municipalities within the geografic area and with access to occupational therapy

You may not qualify if:

• comorbidity of dementia or severe developmental disability
• not being able to communicate in Swedish
• currently being in acute psychosis, or acute suicidal risk

Sponsors & Collaborators

• Umeå University: lead
• Swedish Council for Working Life and Social Research: collaborator

Study Sites (1)

Umeå university

Umeå, 901 87, Sweden

Location

Related Publications (3)

• Sjoberg A, Liv P, Lindstrom M. Effect of Everyday Life Rehabilitation on recovering quality of life in individuals with serious mental illness in supported accommodation: a pragmatic cluster randomised controlled trial. BMJ Ment Health. 2025 Aug 7;28(1):e301757. doi: 10.1136/bmjment-2025-301757.

  PMID: 40780841 DERIVED

• Lindstrom M. Development of the Everyday Life Rehabilitation model for persons with long-term and complex mental health needs: Preliminary process findings on usefulness and implementation aspects in sheltered and supported housing facilities. Front Psychiatry. 2022 Aug 16;13:954068. doi: 10.3389/fpsyt.2022.954068. eCollection 2022.

  PMID: 36051549 DERIVED

• Lindstrom M, Lindholm L, Liv P. 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. Trials. 2022 Aug 15;23(1):657. doi: 10.1186/s13063-022-06622-0.

  PMID: 35971130 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Autistic Disorder; Mental Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Officials

• Maria Lindström, PhD

  Umeå university, Dept of Community Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant professor

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: September 24, 2021
• Study Start: September 15, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

SE (1)