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
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
-
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.