Condition category
Circulatory System
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
30/10/2009
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

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

http://www.dh.gov.uk/en/index.htm

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

  1. 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.

Additional files

Editorial Notes