Condition category
Not Applicable
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
17/12/2009
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 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

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19712593

Publication citations

  1. 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.

Additional files

Editorial Notes