Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RCRC9C YOUNG R&D
Study information
Scientific title
Acronym
Study hypothesis
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.
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
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiovascular diseases: Cerebrovascular disease
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Knowledge about Stroke and Service questionnaire
2. London Handicap Scale
Secondary outcome measures
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.
Overall trial start date
11/01/1999
Overall trial end date
12/01/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Other
Gender
Not Specified
Target number of participants
220
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
11/01/1999
Recruitment end date
12/01/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bradford Hospitals NHS Trust
Bradford
BD5 0NA
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (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
Basic results (scientific)
Publication list
2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/15573828
Publication citations
-
Results
Smith J, Forster A, Young J, A randomized trial to evaluate an education programme for patients and carers after stroke., Clin Rehabil, 2004, 18, 7, 726-736.