Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000250437
Ethics application status
Approved
Date submitted
9/05/2007
Date registered
10/05/2007
Date last updated
30/08/2024
Date data sharing statement initially provided
30/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Schizophrenia Treatment Adherence Investigation (STAI)
Scientific title
Treatment review and feedback program to determine risk of poor medication adherence in patients with schizophrenia or schizoaffective disorder.
Universal Trial Number (UTN)
Trial acronym
STAI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia or Schizoaffective disorder 1789 0
Condition category
Condition code
Mental Health 1875 1875 0 0
Schizophrenia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This treatment review is designed to assess medication adherence in subjects with schizophrenia or schizoaffective disorder. Subjects will not be given any interventional treatments as part of this review. The duration of participant observation for this treatment review is 12 months.
Intervention code [1] 1745 0
None
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2663 0
The primary outcome of this treatment review is to quantify the risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia.
Timepoint [1] 2663 0
Participant medication adherence will be assessed at baseline, 6 month follow up and 12 month follow up. Follow up will consist of a review of the participants medical records only.
Secondary outcome [1] 4521 0
1. Reporting on the proportion of patients with schizophrenia who may be inappropriately clinically and/or medically treated in the context of their medication adherence risk status.
Timepoint [1] 4521 0
Participant medication adherence will be assessed at baseline, 6 month follow up and 12 month follow up. Follow up will consist of a review of the participants medical records only.
Secondary outcome [2] 4522 0
2. Quantifying any antipsychotic medication modification and relating this to the treatment review factors captured at baseline.
Timepoint [2] 4522 0
Participant medication adherence will be assessed at baseline, 6 month follow up and 12 month follow up. Follow up will consist of a review of the participants medical records only.
Secondary outcome [3] 4523 0
3. Relating the adherence risk status to the medications used and the actual acute exacerbation rate.
Timepoint [3] 4523 0
Participant medication adherence will be assessed at baseline, 6 month follow up and 12 month follow up. Follow up will consist of a review of the participants medical records only.

Eligibility
Key inclusion criteria
Clinical diagnosis of Schizophrenia or Schizoaffective Disorder according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition). Currently treated in an outpatient clinic. Over 18 years and able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There is no exclusion criteria for this treatment review.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2007
Actual
26/07/2007
Date of last participant enrolment
Anticipated
Actual
1/09/2008
Date of last data collection
Anticipated
Actual
1/09/2009
Sample size
Target
1000
Accrual to date
Final
550

Funding & Sponsors
Funding source category [1] 2022 0
Commercial sector/Industry
Name [1] 2022 0
Janssen-Cilag Pty Ltd
Country [1] 2022 0
Australia
Funding source category [2] 2777 0
Other
Name [2] 2777 0
N/A
Country [2] 2777 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Janssen-Cilag Pty Ltd
Address
1-5 Khartoum Road,
North Ryde
NSW, 2133
Country
Australia
Secondary sponsor category [1] 1832 0
Commercial sector/Industry
Name [1] 1832 0
Kendle Pty Limited
Address [1] 1832 0
156-158 Drummond Street, Oakleigh, Melbourne, VIC 3166
Country [1] 1832 0
Australia
Secondary sponsor category [2] 2509 0
None
Name [2] 2509 0
N/A
Address [2] 2509 0
N/A
Country [2] 2509 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3749 0
Sydney South West Area Health
Ethics committee address [1] 3749 0
Ethics committee country [1] 3749 0
Australia
Date submitted for ethics approval [1] 3749 0
Approval date [1] 3749 0
Ethics approval number [1] 3749 0
Ethics committee name [2] 3750 0
Bellberry limited
Ethics committee address [2] 3750 0
Ethics committee country [2] 3750 0
Date submitted for ethics approval [2] 3750 0
Approval date [2] 3750 0
01/07/2007
Ethics approval number [2] 3750 0
Ethics committee name [3] 3751 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [3] 3751 0
Ethics committee country [3] 3751 0
Australia
Date submitted for ethics approval [3] 3751 0
Approval date [3] 3751 0
Ethics approval number [3] 3751 0
Ethics committee name [4] 3752 0
Alfred Hospital Ethics Committee
Ethics committee address [4] 3752 0
Ethics committee country [4] 3752 0
Australia
Date submitted for ethics approval [4] 3752 0
Approval date [4] 3752 0
Ethics approval number [4] 3752 0
Ethics committee name [5] 239494 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [5] 239494 0
Ethics committee country [5] 239494 0
Australia
Date submitted for ethics approval [5] 239494 0
Approval date [5] 239494 0
Ethics approval number [5] 239494 0
Ethics committee name [6] 239495 0
Queensland Health Human Research Ethics Committee
Ethics committee address [6] 239495 0
Ethics committee country [6] 239495 0
Australia
Date submitted for ethics approval [6] 239495 0
Approval date [6] 239495 0
Ethics approval number [6] 239495 0
Ethics committee name [7] 239496 0
Austin Health Human Research Ethics Committee
Ethics committee address [7] 239496 0
Ethics committee country [7] 239496 0
Australia
Date submitted for ethics approval [7] 239496 0
Approval date [7] 239496 0
Ethics approval number [7] 239496 0
Ethics committee name [8] 239497 0
Gold Coast Health Service District
Ethics committee address [8] 239497 0
Ethics committee country [8] 239497 0
Australia
Date submitted for ethics approval [8] 239497 0
Approval date [8] 239497 0
Ethics approval number [8] 239497 0
Ethics committee name [9] 239498 0
ACT Health Human Research Ethics Committee
Ethics committee address [9] 239498 0
Ethics committee country [9] 239498 0
Australia
Date submitted for ethics approval [9] 239498 0
Approval date [9] 239498 0
Ethics approval number [9] 239498 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27848 0
Address 27848 0
Country 27848 0
Phone 27848 0
Fax 27848 0
Email 27848 0
Contact person for public queries
Name 10934 0
Dr Bev Menner
Address 10934 0
20 Atherton Rd, Oakleigh, Vic, 3166
Country 10934 0
Australia
Phone 10934 0
+61 3 95677622
Fax 10934 0
+61 3 96548336
Email 10934 0
[email protected]
Contact person for scientific queries
Name 1862 0
Dr Bev Menner
Address 1862 0
20 Atherton Rd, Oakleigh, Vic, 3166
Country 1862 0
Australia
Phone 1862 0
+61 3 95677622
Fax 1862 0
+61 3 96548336
Email 1862 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers.
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Conditions for requesting access:
• -

What individual participant data might be shared?
• All data.
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

What types of analyses could be done with individual participant data?
• Any analysis in expected research proposal.
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

When can requests for individual participant data be made (start and end dates)?
From:
No end date determined.
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.