NCT00126295

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2 stroke

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2005

Completed
Last Updated

August 19, 2005

Status Verified

August 1, 2005

First QC Date

August 2, 2005

Last Update Submit

August 18, 2005

Conditions

Outcome Measures

Primary Outcomes (7)

  • knowledge about stroke

  • self-efficacy

  • anxiety

  • depression

  • perceived health status (patients only)

  • satisfaction with the content and presentation of the information received

  • desire for additional information

Interventions

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brisbane Hospital

Brisbane, Queensland, 4029, Australia

Location

Related Publications (1)

  • Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
ECT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 3, 2005

Study Start

June 1, 2003

Study Completion

May 1, 2005

Last Updated

August 19, 2005

Record last verified: 2005-08

Locations