Evaluation of the impact of carer information and support on patients, carers and service utilisation following hospital discharge stroke

ISRCTN	ISRCTN25954820
DOI	https://doi.org/10.1186/ISRCTN25954820
Protocol serial number	PSI F-4
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 11/05/2018

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

Prof Lalit Kalra
Scientific

Department of Health Care for the Elderly
Guy's and St Thomas' School of Medicine
King's Denmark Hill Campus
Bessemer Road
London
SE5 9PJ
United Kingdom

Phone	+44 (0)20 7346 3195
Email	lalit.kalra@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Evaluation of the impact of carer information and support on patients, carers and service utilisation following hospital discharge stroke
Study objectives	This study will 1. Define the role of carers and voluntary sector organisations in supporting mainstream services 2. Define the nature of interventions and interactions required to fulfill this role 3. Define the training needs of carers and volunteers 4. Evaluate the feasibility and acceptability of carer training and support to parents, carers and professionals 5. Evaluate the effectiveness of carer training and/or support in improving outcome and reducing service use (cost effectiveness) 6. Examine the resource implications and potential savings (cost effectiveness) of input directed towards supporting carers
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular diseases: Cerebrovascular disease
Intervention	1. Formal training of carers in basic rehabilitation techniques and early support from a voluntary carer organisation which will continue after discharge. 2. Control interventions will comprise informal instruction on disability to carers and information on carer services but no pre-arranged carer support after discharge.
Intervention type	Other
Primary outcome measure(s)	1. Social and health services resource use 2. Mortality 3. Institutionalisation 4. Admission/re-admission to hospitals 5. Mobility (final and change over time) 6. Barthel ADL score (final and change over time) 7. Patient and career quality of life measures (SF-36) 8. Carer stress 9. Patient/carer satisfaction 10. Acceptability of intervention
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/12/2001

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	The study will include stroke survivors of any age with the following characteristics: 1. Independent for personal activities of daily living (ADL) prior to stroke. (Pre-morbid Barthel Index>15). 2. Discharge home is the planned outcome. 3. Residual disability defined as the need for supervision or physical assistance for transfers, mobility or personal activities of daily living. 4. Presence of a carer at home. 5. Requirement of social or health services support package following discharge for continuing care needs. 6. Patient and carer consent to participation in the study.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/1997
Date of final enrolment	01/12/2001

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

King's College School of Medicine and Dentistry

Department of Health Care for the Elderly
London
SE5 9PJ
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	08/05/2004		Yes	No

Editorial Notes

11/05/2018: Publication reference added.
01/03/2016: No publications found, verifying study status with principal investigator.