Promoting Adherence to Treatment in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Promoting Adherence to Treatment in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125267
• Other study ID #: 5R01MH064542-05
• Secondary ID: 5R01MH064542-05
• Status: Completed
• Phase: N/A
• First received: May 17, 2010
• Last updated: May 17, 2010
• Start date: April 2003
• Est. completion date: October 2008

Study information

• Verified date: May 2010
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

As above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: October 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• multifamily group-adherence
multifamily groups held twice a month for one year focused on improving medication adherence using techniques derived from the Theory of Planned Behavior
• multifamily group-standard
multifamily groups held twice a month focused on general problem solving method

Locations

Country	Name	City	State
United States	San Fernando Mental Health Center	Granada Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants who are Hospitalized in a Psychiatric Inpatient Unit	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.	two years	No
Secondary	Number of participants who are at least 80% adherent to their antipsychotic medication regimens during a particular assessment period	Multi-modal method of assessing medication adherence including pill count, pharmacy records and interviews of patient, key relative and treating psychiatrist. Using the Treatment Compliance Interview, participants will be rated as either non-adherent (less than 50% adherence), partially adherent (50%-79% adherent) or fully adherent (80% or greater).	two years	No