Condition category
Circulatory System
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
27/08/2009
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 Lalit Kalra

ORCID ID

Contact details

Department of Medicine
Guy's
King's & St Thomas' School of Medicine
Bessemer Road
London
SE5 9PJ
United Kingdom
+44 (0)20 7346 3487
lalit.kalra@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 93/03/26

Study information

Scientific title

Acronym

Study hypothesis

A randomised controlled trial comparing outcome and resource use in acute stroke patients managed at home by a multidisciplinary stroke team, managed on general wards under the supervision of a stroke team or managed on a stroke unit will be undertaken to provide information of the effectiveness of alternate strategies of stroke management.

The study will provide information on:
1. The relative effectiveness of each model of stroke care.
2. Criteria to identify stroke patients suitable for domiciliary management and those who will require hospitalisation.
3. The relationship between resource use and outcome in alternative models of stroke care.
4. The acceptability of domiciliary acute stroke management to patients, family/carers and general practitioners.

The data collected also will provide prospective validation for criteria for hospital admission for stroke, information on the impact of interdisciplinary collaboration, intensity and timing of therapy input and liaison between health and social services on outcome and resource utilisation for each alternate strategy.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cardiovascular diseases: Cerebrovascular disease

Intervention

1. Acute stroke patients managed at home by a multidisciplinary stroke team
2. Managed on general wards under the supervision of a stroke team
3. Managed on a stroke unit

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Death or institutionalisation at 12 months

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/04/1995

Overall trial end date

31/03/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Patients recently suffering from stroke

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

457

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/04/1995

Recruitment end date

31/03/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Medicine
London
SE5 9PJ
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

2000 results in http://www.ncbi.nlm.nih.gov/pubmed/11036894

Publication citations

  1. Results

    Kalra L, Evans A, Perez I, Knapp M, Donaldson N, Swift CG, Alternative strategies for stroke care: a prospective randomised controlled trial., Lancet, 2000, 356, 9233, 894-899, doi: 10.1016/S0140-6736(00)02679-9.

Additional files

Editorial Notes