Schizophrenia Treatment Adherence Investigation (STAI)
April 8, 2014 updated by: Janssen-Cilag Pty Ltd
Clinical Audit and Feedback Program to Determine Risk for Medication Adherence in Outpatients Diagnosed With Schizophrenia in Australia
The primary objective of this treatment review and feedback program is to quantify the risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this treatment review and feedback program is to quantify the risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia.
Observational study - no study drug administered
Study Type
Observational
Enrollment (Actual)
550
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Outpatient clinics
Description
Inclusion Criteria:
- Clinical diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV
- Currently treated in an outpatient clinic
- Able to provide informed consent
- Concurrent enrolment in clinical trials is acceptable
- Have completed all questions on the Drug Attitude Inventory (DAI-10) and Medication Adherence Rating Scale (MARS) survey
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
001
|
Examination of risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Primary outcome measure is the Clinical Assessment of Adherence as rated by the Investigators
Time Frame: 6 months, 12 months
|
6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Clinical exacerbations (worsening of symptoms)
Time Frame: 6 mths, 12 mths
|
6 mths, 12 mths
|
|
Medication changes
Time Frame: 6 mths, 12 mths
|
6 mths, 12 mths
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
October 23, 2009
First Submitted That Met QC Criteria
October 23, 2009
First Posted (Estimate)
October 26, 2009
Study Record Updates
Last Update Posted (Estimate)
April 9, 2014
Last Update Submitted That Met QC Criteria
April 8, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR013822
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.