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
Other: Risk status for medication adherence
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

Janssen-Cilag Pty Ltd

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

Keywords

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.

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