A randomised trial of a comprehensive stroke information service for patients and carers.

ISRCTN ISRCTN63480886
DOI https://doi.org/10.1186/ISRCTN63480886
Protocol serial number HSR/067 R180/05588
Sponsor NHS R&D Regional Programme Register - Department of Health (UK)
Funder NHS Executive Northern and Yorkshire (UK)
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
21/01/2010
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

Dr Helen Rodgers
Scientific

Centre for Health Services Research
21 Claremont Place
Newcastle University
Newcastle upon Tyne
NE2 4AA
United Kingdom

Email helen.rodgers@ncl.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCerebrovascular disease
Intervention1. 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date31/05/1998

Eligibility

Participant type(s)Patient
Age groupOther
SexAll
Target sample size at registration380
Key inclusion criteriaIn-patients and their carers, randomised within one week of stroke or when mentally stable
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment06/01/1996
Date of final enrolment31/05/1998

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Centre for Health Services Research
Newcastle upon Tyne
NE2 4AA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/1999 Yes No