Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
21/01/2010
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

Dr Helen Rodgers

ORCID ID

Contact details

Centre for Health Services Research
21 Claremont Place
Newcastle University
Newcastle upon Tyne
NE2 4AA
United Kingdom
helen.rodgers@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HSR/067 R180/05588

Study information

Scientific title

Acronym

Study hypothesis

To determine the effectiveness of a multi-disciplinary Stroke Education Programme for stroke patients and their informal carers in improving health status, by enhancing their knowledge of the causes and consequences of stroke and the availability of community support

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cerebrovascular disease

Intervention

1. Stroke educational programme (SEP):
One 1-hour small group educational session for inpatients followed by six 1-hour sessions after discharge
2. A control group to receive conventional stroke unit care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Patient and informal carer perceived health status (SF-36) at six months post stroke

Secondary outcome measures

1. Knowledge of stroke
2. Satisfaction with services
3. Emotional outcomes of patients and informal carers
4. Informal carer stress
5. Disability

Overall trial start date

06/01/1996

Overall trial end date

31/05/1998

Reason abandoned

Eligibility

Participant inclusion criteria

In-patients and their carers, randomised within one week of stroke or when mentally stable

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

204 patients, 176 carers (added 21/01/10; see publication)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

06/01/1996

Recruitment end date

31/05/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Health Services Research
Newcastle upon Tyne
NE2 4AA
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

1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10582982

Publication citations

  1. Results

    Rodgers H, Atkinson C, Bond S, Suddes M, Dobson R, Curless R, Randomized controlled trial of a comprehensive stroke education program for patients and caregivers., Stroke, 1999, 30, 12, 2585-2591.

Additional files

Editorial Notes