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ISRCTN
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ISRCTN41666882
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ClinicalTrials.gov identifier
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Public title
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A randomised trial to evaluate improved routine communication to patients and carers after stroke
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Scientific title
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Acronym
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N/A
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Serial number at source
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RCRC9C YOUNG R&D
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Study hypothesis
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The provision of clear information following a stroke has been identified as a key component of good care by both health professionals and patients. The provision to the patient and family of understandable, appropriate and correct information may be effective in positively influencing post-stroke home care. However, a number of recent reports have demonstrated that the implementation of this policy into routine practice may be difficult to achieve. Several small studies in the UK have highlighted the difficulties in successfully implementing strategies for information provision. No evidence of effectiveness in reducing anxiety or improving social functioning has been reported but there was a suggestion that the patients were more satisfied with their level of knowledge and appreciated booklets. It is likely that the method of delivering the information is as important as its content. Simply providing information, particularly when set in a complex area such as stroke, may be too simplistic as it is too passive an approach.
A more active, educational approach may be successful. Thus a formal educational or teaching programme specifically designed for patients and carers may have some special relevance. Such an experimental educational programme was established and evaluated in the USA and reported positive effects including improving caregiver stroke knowledge and family coping strategies. To develop this work further we are going to evaluate by randomised trial the effectiveness of a short educational programme for patients and caregivers after stroke.
Research Questions
1. That a structured package of information provision for patients recovering from stroke and their carers is associated with improved to usual (unstructured) information provision.
2. That a structured package delivered by a facilitator is more effective than either simple provision of the structured information, or usual care.
The primary outcome of interest is patient and carer understanding of stroke, with a secondary outcome of reduction in handicap.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular diseases: Cerebrovascular disease
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Participants - inclusion criteria
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The Bradford Stroke Unit receives patients of any age shortly after stroke onset (average 11 days) who are sufficiently medically stable to participate in a rehabilitation programme. On admission patients and their carers (if available) will be screened for recruitment into the trial within three days of transfer. Patients will be eligible for the trial if they have a diagnosis of acute stroke and give informed consent. Thus we will be recruiting a heterogeneous study sample of patients (n=220) with various stroke impairments and differing ethnic backgrounds. For patients with server aphasia or stroke related cognitive impairment the main emphasis of the information provision will be directed toward the main carer.
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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11/01/1999
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Anticipated end date
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12/01/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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220
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Interventions
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1. Group 1 Unstructured information provision
2. Group 2 Structured information provision - the Stroke Recovery Programme
3. Group 3 Stroke Recovery Programme delivered by a facilitator
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Primary outcome measure(s)
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1. Knowledge about Stroke and Service questionnaire
2. London Handicap Scale
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Secondary outcome measure(s)
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1. Patients will be asked to complete
1.1. Patients Satisfaction Questionnaire
1.2. Frenchay Activities Index
1.3. Hospital Anxiety and Depression Scale
2. Carers will be asked to complete
2.1. General Health Questionnaire
2.2. Carers Satisfaction Questionnaire
An estimate of the resource use will be made by recording the time taken by the three specialist nurses during the one-to-one sessions with patients and carers.
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Sources of funding
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NHS Executive Northern and Yorkshire (UK)
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Trial website
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Publications
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2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/15573828
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Contact name
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Prof
John
Young
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Address
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Bradford Hospitals NHS Trust
St Luke's Hospital
Little Horton Lane
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City/town
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Bradford
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Zip/Postcode
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BD5 0NA
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Country
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United Kingdom
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Tel
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+44 (0)1274 365 311
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Fax
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+44 (0)1274 365 260
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Email
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youngj@bhtgwise.mhs.compuserve.com
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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25/11/2010
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Date ISRCTN assigned
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23/01/2004
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