Evaluation of an Individualised Written Education Package for Stroke Patients

Stroke Clinical Trial

Official title:

Evaluation of a Computer-Generated Individualised Written Education Package for Patients Following Stroke and Their Carers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126295
• Other study ID #: 2002000023
• Status: Completed
• Phase: Phase 2
• First received: August 2, 2005
• Last updated: August 18, 2005
• Start date: June 2003
• Est. completion date: May 2005

Study information

• Verified date: August 2005
• Source: Medical Benefits Fund of Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 'What you need to know about stroke' education package

Locations

Country	Name	City	State
Australia	Royal Brisbane Hospital	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Medical Benefits Fund of Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knowledge about stroke
Primary	self-efficacy
Primary	anxiety
Primary	depression
Primary	perceived health status (patients only)
Primary	satisfaction with the content and presentation of the information received
Primary	desire for additional information