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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00126295




Registration number
NCT00126295
Ethics application status
Date submitted
2/08/2005
Date registered
3/08/2005
Date last updated
19/08/2005

Titles & IDs
Public title
Evaluation of an Individualised Written Education Package for Stroke Patients
Scientific title
Evaluation of a Computer-Generated Individualised Written Education Package for Patients Following Stroke and Their Carers
Secondary ID [1] 0 0
2002000023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - 'What you need to know about stroke' education package

Treatment: Devices: 'What you need to know about stroke' education package
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
knowledge about stroke
Timepoint [1] 0 0
Primary outcome [2] 0 0
self-efficacy
Timepoint [2] 0 0
Primary outcome [3] 0 0
anxiety
Timepoint [3] 0 0
Primary outcome [4] 0 0
depression
Timepoint [4] 0 0
Primary outcome [5] 0 0
perceived health status (patients only)
Timepoint [5] 0 0
Primary outcome [6] 0 0
satisfaction with the content and presentation of the information received
Timepoint [6] 0 0
Primary outcome [7] 0 0
desire for additional information
Timepoint [7] 0 0

Eligibility
Key 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.
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Educational/counselling/training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medical Benefits Fund of Australia
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00126295
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tammy C Hoffmann
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00126295