A randomised trial to evaluate improved routine communication to patients and carers after stroke

ISRCTN ISRCTN41666882
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

Bradford Hospitals NHS Trust
St Luke's Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom

Phone +44 (0)1274 365 311

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesThe 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) studiedCardiovascular diseases: Cerebrovascular disease
Intervention1. 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 typeOther
Primary outcome measure1. Knowledge about Stroke and Service questionnaire
2. London Handicap Scale
Secondary outcome measures1. 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 date11/01/1999
Completion date12/01/2002

Eligibility

Participant type(s)Patient
Age groupOther
SexNot Specified
Target number of participants220
Key inclusion criteriaThe 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 criteriaDoes not match inclusion criteria
Date of first enrolment11/01/1999
Date of final enrolment12/01/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Bradford Hospitals NHS Trust
Bradford
BD5 0NA
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

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

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2004 Yes No