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Promoting Adherence to Treatment in Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
multifamily group-adherence
multifamily group-standard
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring medication adherence, schizophrenia, Mexican American, multifamily groups

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Fernando Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

multifamily group-adherence

multifamily group-standard

treatment as usual

Arm Description

multifamily group treatment with a focus on improving adherence to antipsychotic medication

multifamily group focused on problems identified by group participants

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
May 17, 2010
Last Updated
May 17, 2010
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01125267
Brief Title
Promoting Adherence to Treatment in Schizophrenia
Official Title
Promoting Adherence to Treatment in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
medication adherence, schizophrenia, Mexican American, multifamily groups

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
multifamily group-adherence
Arm Type
Experimental
Arm Description
multifamily group treatment with a focus on improving adherence to antipsychotic medication
Arm Title
multifamily group-standard
Arm Type
Active Comparator
Arm Description
multifamily group focused on problems identified by group participants
Arm Title
treatment as usual
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
multifamily group-adherence
Intervention Description
multifamily groups held twice a month for one year focused on improving medication adherence using techniques derived from the Theory of Planned Behavior
Intervention Type
Behavioral
Intervention Name(s)
multifamily group-standard
Intervention Description
multifamily groups held twice a month focused on general problem solving method
Primary Outcome Measure Information:
Title
Number of Participants who are Hospitalized in a Psychiatric Inpatient Unit
Description
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.
Time Frame
two years
Secondary Outcome Measure Information:
Title
Number of participants who are at least 80% adherent to their antipsychotic medication regimens during a particular assessment period
Description
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).
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex J Kopelowicz, MD
Organizational Affiliation
Geffen School of Medicine at UCLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Fernando Mental Health Center
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22393219
Citation
Kopelowicz A, Zarate R, Wallace CJ, Liberman RP, Lopez SR, Mintz J. The ability of multifamily groups to improve treatment adherence in Mexican Americans with schizophrenia. Arch Gen Psychiatry. 2012 Mar;69(3):265-73. doi: 10.1001/archgenpsychiatry.2011.135.
Results Reference
derived

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Promoting Adherence to Treatment in Schizophrenia

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