A randomised controlled trial to evaluate the cost-effectiveness of a domiciliary rehabilitation scheme versus usual care in the rehabilitation of stroke patients.

ISRCTN	ISRCTN19287811
DOI	https://doi.org/10.1186/ISRCTN19287811
Protocol serial number	N/A
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive South West (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 15/01/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Roderick
Scientific

Institute of Public Health Medicine
University of Southampton
Level B, South Academic Block
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Phone	+44 (0)2380 796 532
Email	pjr@soton.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	1. To evaluate the outcomes of a new domiciliary rehabilitation service for stroke patients and their carers in comparison with the usual care provided in geriatric day hospitals. 2. To estimate the costs of the different approaches and to thereby determine the relative cost-effectiveness of the two models.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cerebrovascular disease
Intervention	1. Domiciliary rehabilitation 2. Care from geriatric day hospitals
Intervention type	Other
Primary outcome measure(s)	Assessments at baseline 3, 6 and 12 months post entry to study. 1. Patient functional status and quality of life: 1.1. Barthel index 1.2. Rivermead mobility index 1.3. Philadelphia Geriatric Morale Scale 1.4. Frenchay Activities Index 1.5. SF36 2. Carer outcomes: 2.1. Carer strain index 2.2. SF36 2.3.GHQ 3. Resource use 3.1. NHS: 3.1.1. rehabilitation 3.1.2. inpatient/outpatient 3.1.3. GP 3.1.4. district nurse 3.1.5. speech therapy 3.2. Social services: 3.2.1. home help 3.2.2. meal on wheels 3.2.3. day centre 4. Costs of domiciliary rehabilitation, day hospital visit including transport
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/1997

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	140
Key inclusion criteria	Stroke patients age 55+ who required rehabilitation post discharge
Key exclusion criteria	Terminal illness, need for day hospital care for social or medical reasons
Date of first enrolment	01/04/1995
Date of final enrolment	31/12/1997

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Public Health Medicine

Southampton
SO16 6YD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2001		Yes	No