Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00126295