Schizophrenia Treatment Adherence Investigation (STAI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier:
NCT01001481
First received: October 23, 2009
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Other: Risk status for medication adherence
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Audit and Feedback Program to Determine Risk for Medication Adherence in Outpatients Diagnosed With Schizophrenia in Australia

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Pty Ltd:

Primary Outcome Measures:
  • Primary outcome measure is the Clinical Assessment of Adherence as rated by the Investigators [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical exacerbations (worsening of symptoms) [ Time Frame: 6 mths, 12 mths ] [ Designated as safety issue: No ]
  • Medication changes [ Time Frame: 6 mths, 12 mths ] [ Designated as safety issue: No ]

Enrollment: 550
Study Start Date: July 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001 Other: Risk status for medication adherence
Examination of risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatient clinics

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001481

Sponsors and Collaborators
Janssen-Cilag Pty Ltd
Investigators
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
  More Information

No publications provided

Responsible Party: Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier: NCT01001481     History of Changes
Other Study ID Numbers: CR013822
Study First Received: October 23, 2009
Last Updated: April 8, 2014
Health Authority: Australia: Department of Health

Keywords provided by Janssen-Cilag Pty Ltd:
Treatment review
Schizophrenia
Observational
Prospective studies
Australia

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014