Promoting Adherence to Treatment in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01125267
First received: May 17, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted

May 17, 2010
May 17, 2010
April 2003
September 2007   (final data collection date for primary outcome measure)
Number of Participants who are Hospitalized in a Psychiatric Inpatient Unit [ Time Frame: two years ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
Number of participants who are at least 80% adherent to their antipsychotic medication regimens during a particular assessment period [ Time Frame: two years ] [ Designated as safety issue: No ]
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).
Same as current
Not Provided
Not Provided
 
Promoting Adherence to Treatment in Schizophrenia
Promoting Adherence to Treatment in Schizophrenia

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.

As above

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
  • 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
  • Behavioral: multifamily group-standard
    multifamily groups held twice a month focused on general problem solving method
  • Experimental: multifamily group-adherence
    multifamily group treatment with a focus on improving adherence to antipsychotic medication
    Intervention: Behavioral: multifamily group-adherence
  • Active Comparator: multifamily group-standard
    multifamily group focused on problems identified by group participants
    Intervention: Behavioral: multifamily group-standard
  • No Intervention: treatment as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
October 2008
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01125267
5R01MH064542-05, 5R01MH064542-05
No
Alex Kopelowicz, M.D., David Geffen School of Medicine at UCLA
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Principal Investigator: Alex J Kopelowicz, MD Geffen School of Medicine at UCLA
University of California, Los Angeles
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP