A randomised trial to evaluate improved routine communication to patients and carers after stroke
ISRCTN | ISRCTN41666882 |
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DOI | https://doi.org/10.1186/ISRCTN41666882 |
Secondary identifying numbers | RCRC9C YOUNG R&D |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 02/10/2012
- 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 John Young
Scientific
Scientific
Bradford Hospitals NHS Trust
St Luke's Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom
Phone | +44 (0)1274 365 311 |
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Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Other |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 11/01/1999 |
Completion date | 12/01/2002 |
Eligibility
Participant type(s) | Patient |
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Age group | Other |
Sex | Not Specified |
Target number of participants | 220 |
Key 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. |
Key exclusion criteria | Does not match inclusion criteria |
Date of first enrolment | 11/01/1999 |
Date of final enrolment | 12/01/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bradford Hospitals NHS Trust
Bradford
BD5 0NA
United Kingdom
BD5 0NA
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/11/2004 | Yes | No |