Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study 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
Primary outcome measure
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 study start date
01/04/1997
Overall study end date
01/12/2001
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Not Specified
Sex
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
England, United Kingdom
Study 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
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/05/2004 | Yes | No |