Contact information
Type
Scientific
Primary contact
Prof David Barer
ORCID ID
Contact details
Department of Medicine (Geriatric Medicine)
University of Newcastle upon Tyne
Queen Elizabeth Hospital
Newcastle upon Tyne
NE9 6SX
United Kingdom
+44 (0)191 445 2850
D.H.Barer@NCL.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 93/03/11
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration.
Study design
Randomised controlled trial with a factorial design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Condition
Stroke patients
Intervention
1. Social rehabilitation
2. Psychological rehabilitation
3. Physical rehabilitation
4. Standard care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/12/1995
Overall trial end date
30/11/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Patients having recently suffered a stroke
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/12/1995
Recruitment end date
30/11/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Medicine (Geriatric Medicine)
Newcastle upon Tyne
NE9 6SX
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
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
2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11237160
Publication citations
-
Results
Parker CJ, Gladman JR, Drummond AE, Dewey ME, Lincoln NB, Barer D, Logan PA, Radford KA, A multicentre randomized controlled trial of leisure therapy and conventional occupational therapy after stroke. TOTAL Study Group. Trial of Occupational Therapy and Leisure., Clin Rehabil, 2001, 15, 1, 42-52.