Condition category
Not Applicable
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
28/10/2016
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 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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes

28/10/2016: No publications found, verifying study status with principal investigator