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Clinical Trials/NCT01125267
NCT01125267
Completed
Not Applicable

Promoting Adherence to Treatment in Schizophrenia

University of California, Los Angeles1 site in 1 country174 target enrollmentApril 2003
ConditionsSchizophrenia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
University of California, Los Angeles
Enrollment
174
Locations
1
Primary Endpoint
Number of Participants who are Hospitalized in a Psychiatric Inpatient Unit
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

The project evaluates a culturally adapted, family-based intervention designed to promote treatment adherence among Mexican-Americans with schizophrenia using a randomized, controlled design in a public mental health setting. Mexican-American patients with schizophrenia and their families were randomly assigned to either: 1) one year of multi- family groups that emphasize the importance of attitudes towards adherence, subjective norms, and self-perceived and actual adherence skills in maintaining adherence, added to ongoing customary outpatient care; 2) standard multi-family groups without an emphasis on medication adherence, added to customary outpatient care; or 3) customary outpatient care only (monthly pharmacotherapy sessions and additional services as clinically needed). The study hypotheses are that subjects assigned to the adapted multi-family group would have better medication adherence, less psychiatric symptoms and fewer psychiatric hospitalizations throughout the course of the study (one year of treatment and one year of follow up) compared to the comparison conditions.

Detailed Description

As above

Registry
clinicaltrials.gov
Start Date
April 2003
End Date
October 2008
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • DSM-IV diagnosis of schizophrenia or schizoaffective disorder;
  • Between 18 and 50 years of age;
  • Of Mexican origin and speaks Spanish fluently;
  • Was without antipsychotic medication without medical authorization for one continuous week in the month prior to hospitalization;
  • Was living with his/her family of origin immediately preceding the inpatient stay and would return to live with his/her family after discharge; and
  • The patient and at least one family member were willing to participate.

Exclusion Criteria

  • Patient on conservatorship or legal guardian status

Outcomes

Primary Outcomes

Number of Participants who are Hospitalized in a Psychiatric Inpatient Unit

Time Frame: two years

Psychiatric hospitalization will be monitored through the use of the Los Angeles County Department of Mental Health Management Information System. This allows for the data capture of all participants who are hospitalized in an inpatient unit anywhere in Los Angeles County throughout the two-yaer course of the study. Although the primary outcome variable is whether or not a participant has been hospitalized within a given assessment period, the number of hospitalizations and the number of days hospitalized across all assessment periods will be assessed, as well.

Secondary Outcomes

  • Number of participants who are at least 80% adherent to their antipsychotic medication regimens during a particular assessment period(two years)

Study Sites (1)

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