Do Self-Report and Physician Impressions of Adherence to Oral Antipsychotic Medication Agree With Objective Data?

Completed

• Conditions: Schizophrenia; Schizoaffective

• Registration Number: NCT00223522
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

The purpose of this study is to prospectively examine adherence to oral atypical antipsychotics in patients with schizophrenia. We are psrticularly interested in examining the level of agreement among self-report, physician impressions and objective measures of adherence. We believe that physicians, casemanagers, and clients significantly overestimate the level of adherence.

Detailed Description

Fifty schizophrenia patients will be recruited at the time of their clinic visit to Tri-County MHMR Services and the El Paso Community MHMR Center. Both physicians and patients will be asked to rate the patient's medication adherence on their index clinic visit. Initial ratings will also occur at this visit. After filling their medication prescription, all subjects will be given electronic medication caps that record each time and date their medication container is opened. Patients will then be followed in the community for the next 12 weeks to observe actual adherence to medication from the index visit to the next successive clinic visit. Every two weeks pills will be counted and data will be retrieved from the electronic medication caps. During the first and last two weeks of study, blood will be sampled on two randomly selected occasions approximately 72 hours apart. Self-report and physician assessment of adherence, symptom and attitudinal measures will be obtained a second time at the second clinic visit 12 weeks after the index visit.

Study Timeline

• Study Start: 2004-04
• Study Completion: 2005-03
• Status Verified: 2005-09
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Last Update Submitted: 2005-09-14
• Study First Posted: 2005-09-22
• Last Update Posted: 2005-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diagnosis of Schizophrenia or Schizoaffective disorder
• Between the ages of 18-55
• no documented history of head injury, mental retardation or neurological disorder

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

UTHSCSA; 🇺🇸 San Antonio, Texas, United States