- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00126295
Evaluation of an Individualised Written Education Package for Stroke Patients
Evaluation of a Computer-Generated Individualised Written Education Package for Patients Following Stroke and Their Carers
The primary aim of the randomised controlled trial was to evaluate the effectiveness of a tailored written education package ("What you need to know about stroke") on the outcomes of:
- Knowledge about stroke, self-efficacy, anxiety, depression, perceived health status, satisfaction with the content and presentation of the information received, and desire for additional information for patients following stroke and
- Knowledge about stroke, self-efficacy, anxiety, depression, satisfaction with the content and presentation of the information received, and desire for additional information for their carers.
A secondary aim was to evaluate the effect of written information on the outcomes of knowledge about stroke, self-efficacy, anxiety, depression, and perceived health status of patients following stroke and on knowledge about stroke, self-efficacy, anxiety, and depression of their carers.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Queensland
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Brisbane, Queensland, Australia, 4029
- Royal Brisbane Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Had a stroke or transient ischemic attack (TIA) or was the informal carer of a person who had a stroke or TIA;
- Had a reported English-proficiency level, corrected hearing and vision, and communication status adequate to participate in an interview and complete assessment tasks;
- Did not have reported or observable dementia;
- Lived within 50km of the hospital, for ease of follow-up; and
- Was medically stable.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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anxiety
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depression
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self-efficacy
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knowledge about stroke
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perceived health status (patients only)
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satisfaction with the content and presentation of the information received
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desire for additional information
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Collaborators and Investigators
Investigators
- Principal Investigator: Tammy C Hoffmann, The University of Queensland
- Principal Investigator: Kryss McKenna, The University of Queensland
- Principal Investigator: Linda Worrall, The University of Queensland
- Principal Investigator: Stephen Read, Royal Brisbane Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2002000023
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