Rehabilitation Effectiveness for Activities for Life
| ISRCTN | ISRCTN25898179 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25898179 |
| Secondary identifying numbers | 5664 |
- Submission date
- 23/04/2010
- Registration date
- 23/04/2010
- Last edited
- 14/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Helen Killaspy
Scientific
Scientific
Department of Mental Health Sciences
University College London
Royal Free Hospital
London
NW3 2PF
United Kingdom
Study information
| Study design | Randomised interventional process of care trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be found at http://www.ucl.ac.uk/REAL-Study/StudyPopulationAndEligibilty.html |
| Scientific title | A multicentre study of rehabilitation services and the efficacy of promoting activities for people with severe mental health problems |
| Study acronym | REAL |
| Study objectives | 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(s) | South East Research Ethics Committee, 16/06/2009, ref: 07/Q0603/26 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 28/07/2009 |
| Completion date | 30/06/2013 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | Planned Sample Size: 900; UK Sample Size: 900 |
| Key inclusion criteria | All rehabilitation services and service users in England |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 28/07/2009 |
| Date of final enrolment | 30/06/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University College London
London
NW3 2PF
United Kingdom
NW3 2PF
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
| rmyadjw@ucl.ac.uk | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 28/08/2013 | Yes | No | |
| Results article | results | 01/01/2015 | Yes | No | |
| Results article | results | 02/09/2015 | Yes | No |
