StrokePhase 2NCT00126295
Evaluation of an Individualised Written Education Package for Stroke Patients
A Phase 2 study testing 'What you need to know about stroke' education package in people with Stroke, run by Medical Benefits Fund of Australia at 1 site in Australia.
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… Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- 'What you need to know about stroke' education package
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2003to May 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- 'What you need to know about stroke' education package
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'What you need to know about stroke' education packageDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2005 (estimated)
- Study startJun 2003
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- Medical Benefits Fund of Australia
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tammy C Hoffmann, Principal investigator, The University of QueenslandKryss McKenna, Principal investigator, The University of QueenslandLinda Worrall, Principal investigator, The University of QueenslandStephen Read, Principal investigator, Royal Brisbane Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126295
- Sponsor's protocol ID
- 2002000023
- Status last verified
- Aug 2005
- First submitted
- 2 Aug 2005
- Last updated
- 19 Aug 2005
- Results posted
- No
Publications
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.
PubMed 34813082
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Computer-Generated Individualised Written Education Package for Patients Following Stroke and Their Carers
- ClinicalTrials.gov ID
- NCT00126295
- Acronym / sponsor ID
- 2002000023
- Conditions
- Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- Medical Benefits Fund of AustraliaIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- May 2005
- First posted
- 3 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'What you need to know about stroke' education package | Device | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2005.
- Derived from this study: PubMed 34813082Crocker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tammy C Hoffmann principal investigator
The University of Queensland
Kryss McKenna principal investigator
The University of Queensland
Linda Worrall principal investigator
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 'What you need to know about stroke' education package in people with Stroke, run by Medical Benefits Fund of Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knowledge about stroke. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00126295, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2005.