Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
01/03/2016
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 Lalit Kalra

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSI F-4

Study information

Scientific title

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1997

Overall trial end date

01/12/2001

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/1997

Recruitment end date

01/12/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College School of Medicine and Dentistry
Department of Health Care for the Elderly
London
SE5 9PJ
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Primary and Secondary Care Interface National Research and Development Programme (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

01/03/2016: No publications found, verifying study status with principal investigator.