Condition category
Mental and Behavioural Disorders
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
14/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helen Killaspy

ORCID ID

Contact details

Department of Mental Health Sciences
University College London
Royal Free Hospital
London
NW3 2PF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5664

Study information

Scientific title

A multicentre study of rehabilitation services and the efficacy of promoting activities for people with severe mental health problems

Acronym

REAL

Study hypothesis

The details for the cluster randomised controlled trial phase of the project are listed here. This is one phase of a larger programme of research that runs for 5 years. The aims and objectives of this study overall are:
1. To investigate current provision and quality of mental health rehabilitation services in England
2. To investigate the clinical and cost effectiveness of an enhanced rehabilitation intervention for poorer quality services
3. To identify the characteristics of mental health rehabilitation services and their service users that are associated with better outcomes

The first phase of the study involves a comprehensive survey of all inpatient rehabilitation units in England to assess the quality of each using a specialised, standardised toolkit that has been developed in another study (the Quality Indicator for Rehabilitative Care [QuIRC]). We will describe current service provision, factors associated with service quality and whether provision is appropriate to local psychiatric morbidity. Services that score below the median on the quality assessment toolkit will be invited to participate in a cluster randomised controlled trial that will test the efficacy of an enhanced rehabilitation intervention (a staff training programme) to facilitate service users' activity (Phase 3). This intervention (the "GetREAL" intervention) will be developed as part of the research programme (Phase 2). At the same time as Phase 3 is being carried out, the other services (that scored above the median on the quality assessment toolkit) will be invited to take part in a cohort study to investigate service and service user characteristics that predict better outcomes such as successful community discharge (Phase 4).

Ethics approval

South East Research Ethics Committee, 16/06/2009, ref: 07/Q0603/26

Study design

Randomised interventional process of care trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Can be found at http://www.ucl.ac.uk/REAL-Study/StudyPopulationAndEligibilty.html

Condition

Topic: Mental Health Research Network; Subtopic: All Diagnoses, Schizophrenia; Disease: Schizophrenia

Intervention

Intervention arm:
Services will receive the GetREAL intervention as developed in Phase 2. One of two GetREAL teams will spend five weeks with each service randomly allocated to receive the GetREAL intervention (i.e. each GetREAL team will work with 8 or 9 services). The GetREAL team comprises an OT, an activity worker and a service user. The GetREAL intervention will include a full training day for all front line staff and a further 4 weeks of hands on work.

Control arm:
Units in the comparison arm will continue to deliver usual care.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Proportion of time service users spend engaged in any activity

Secondary outcome measures

Service users' social functioning as rated using the Life Skills Profile

Overall trial start date

28/07/2009

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

All rehabilitation services and service users in England

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

Planned Sample Size: 900; UK Sample Size: 900

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

28/07/2009

Recruitment end date

30/06/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
NW3 2PF
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom
-
rmyadjw@ucl.ac.uk

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23981710
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26328771
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26359611

Publication citations

Additional files

Editorial Notes