Contact information
Type
Scientific
Primary contact
Prof Pam Enderby
ORCID ID
Contact details
Centre for Ageing and Rehabilitation Studies
Community Sciences Centre
Northern General Hospital NHS Trust
Herries Road
Sheffield
S5 7AU
United Kingdom
+44 (0)114 271 5916
p.m.enderby@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RBG 99XX7
Study information
Scientific title
A randomised controlled trial (RCT) to evaluate the cost-effectiveness and patient and carer satisfaction associated with different levels of intensity of community rehabilitation
Acronym
Study hypothesis
Evaluate and compare the levels of impairment, disability, handicap and well-being among elderly patients receiving either a supplemented CRT service or non-intensive CRT service following stroke or fractured neck of femur. Evaluate and compare the costs, both direct and indirect, of providing intensive community rehabilitation and non-intensive community rehabilitation for elderly patients following stroke or fractured neck of femur. Evaluate and compare levels of patient and informal carer satisfaction with intensive community rehabilitation and non-intensive community rehabilitation. Estimate the cost effectiveness of intensive community rehabilitation intervention versus non-intensive community rehabilitation for elderly patients following stroke or fractured neck of femur.
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
Quality of life
Patient information sheet
Condition
Stroke or fractured neck of femur
Intervention
i. Intensive community rehabilitation service
ii. Standard care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Death at 3 and 12 months. Institutionalisation at 3 and 12 months. Length of stay. Re-admission rates. Use of GP services. Use of other health services. Use of social services.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2000
Overall trial end date
31/12/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Patients aged 65 plus, admitted from their own home to either the Central Sheffield University Hospital or Northern General Hospital following a 'first' stroke or fractured neck of femur.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2000
Recruitment end date
31/12/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Ageing and Rehabilitation Studies
Sheffield
S5 7AU
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Trent (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