Social-environmental, psychological and physical approaches to stroke rehabilitation
| ISRCTN | ISRCTN98029969 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98029969 |
| Protocol serial number | HTA 93/03/11 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 30/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David Barer
Scientific
Scientific
Department of Medicine (Geriatric Medicine)
University of Newcastle upon Tyne
Queen Elizabeth Hospital
Newcastle upon Tyne
NE9 6SX
United Kingdom
| Phone | +44 (0)191 445 2850 |
|---|---|
| D.H.Barer@NCL.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial with a factorial design |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | This COllaborative STroke Audit and Research (COSTAR) group study will evaluate "social", "psychological" or "physical" approaches to rehabilitation of stroke patients in the community, aiming to help families adjust to life after a stroke and reduce long term distress. About 400 patients will be recruited to a randomised controlled trial in Newcastle to receive one, two or none of the interventions in a factorial design allowing the three approaches and the interactions between them to be assessed. This study will be linked with trials of cognitive/behavioural therapy, community occupational therapy and "leisure rehabilitation" being undertaken in Nottingham and with other controlled trials of similar services being planned at other COSTAR centres, in an "epi-analysis" (pre-planned collaboration using standard clinical measures). This large collaboration will provide reliable information on the cost-effectiveness of different forms of community care for stroke patients and their families. Please note that, as of 25 January 2008, the anticipated end date of this ISRCTN record was updated from 29 February 2000 to 30 November 2001. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Stroke patients |
| Intervention | 1. Social rehabilitation 2. Psychological rehabilitation 3. Physical rehabilitation 4. Standard care |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 30/11/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 400 |
| Key inclusion criteria | Patients having recently suffered a stroke |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/12/1995 |
| Date of final enrolment | 30/11/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Medicine (Geriatric Medicine)
Newcastle upon Tyne
NE9 6SX
United Kingdom
NE9 6SX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2001 | Yes | No |
