Contact information
Type
Scientific
Primary contact
Prof Stuart Parker
ORCID ID
Contact details
Sheffield Institute for Studies on Ageing (SISA)
Community Sciences Centre
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
+44 (0)114 271 5891
s.g.parker@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 97/26/01
Study information
Scientific title
Acronym
Study hypothesis
The principal objective of this project is to carry out a pragmatic randomised controlled trial to address the question: what is the effectiveness and cost effectiveness of day hospitals compared with home based rehabilitation for elderly patients? In the first phase of the project, lasting 1 year, the validity of the research question and the feasibility of the proposed study will be examined through scoping analysis, comparison of national survey data recently collected by members of the research group and a pilot study. Potential clinical partners for the second phase of the study will be systematically identified and recruited, during this stage using the survey analyses to provide clinical sites with co-incident day hospital and community rehabilitation services. Provided that the scoping analyses and pilot study confirm that the research question can be adequately addressed in the current NHS and sufficient appropriate clinical partners can be identified and recruited then the second phase, lasting 3 years, will begin. In the second phase a pragmatic randomised controlled trial will be carried out in which 680 patients will be randomised to receive either community based rehabilitation or day hospital based rehabilitation.
Protocol can be found at http://www.hta.ac.uk/protocols/199700260001.pdf
More details can be found at http://www.hta.ac.uk/1218
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
Not applicable
Intervention
Please note that, as of 16 January 2008, the start and end date of this trial have been updated from 1 May 2001 and 30 April 2005 to 1 September 2002 and 31 October 2007, respectively.
Interventions:
Day hospital rehabilitation vs rehabilitation at home
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary outcome will be functional health status measured using the Nottingham extended ADL scale. Subjects will be stratified according to level of handicap and source of referral. Health economic analysis is built into the trial, some condition specific health status outcomes will be used and quality of life issues will be addressed.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/09/2002
Overall trial end date
31/10/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration.
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
680
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/09/2002
Recruitment end date
31/10/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Sheffield Institute for Studies on Ageing (SISA)
Sheffield
S5 7AU
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
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19712593
Publication citations
-
Results
Parker SG, Oliver P, Pennington M, Bond J, Jagger C, Enderby PM, Curless R, Chater T, Vanoli A, Fryer K, Cooper C, Julious S, Donaldson C, Dyer C, Wynn T, John A, Ross D, Rehabilitation of older patients: day hospital compared with rehabilitation at home. A randomised controlled trial., Health Technol Assess, 2009, 13, 39, 1-143, iii-iv, doi: 10.3310/hta13390.