Social-environmental, psychological and physical approaches to stroke rehabilitation

ISRCTN	ISRCTN98029969
DOI	https://doi.org/10.1186/ISRCTN98029969
Secondary identifying numbers	HTA 93/03/11

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

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
Email	D.H.Barer@NCL.ac.uk

Study information

Study design	Randomised controlled trial with a factorial design
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
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	Not provided at time of registration.
Secondary outcome measures	Not provided at time of registration.
Overall study start date	01/12/1995
Completion date	30/11/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Department of Medicine (Geriatric Medicine)

Newcastle upon Tyne
NE9 6SX
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

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?
Results article	results	01/02/2001		Yes	No