Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
02/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Young

ORCID ID

Contact details

Bradford Hospitals NHS Trust
St Luke's Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom
+44 (0)1274 365 311

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/15573828

Publication citations

  1. 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.

Additional files

Editorial Notes