Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-02-27 @ 8:28 AM
Study NCT ID:
NCT01125267
Status:
COMPLETED
Last Update Posted:
2010-05-18
First Post:
2010-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Adherence to Treatment in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-17', 'studyFirstSubmitDate': '2010-05-17', 'studyFirstSubmitQcDate': '2010-05-17', 'lastUpdatePostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants who are Hospitalized in a Psychiatric Inpatient Unit', 'timeFrame': 'two years', '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.'}], 'secondaryOutcomes': [{'measure': 'Number of participants who are at least 80% adherent to their antipsychotic medication regimens during a particular assessment period', 'timeFrame': 'two years', '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).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['medication adherence', 'schizophrenia', 'Mexican American', 'multifamily groups'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '22393219', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'As above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV diagnosis of schizophrenia or schizoaffective disorder;\n* Between 18 and 50 years of age;\n* Of Mexican origin and speaks Spanish fluently;\n* Was without antipsychotic medication without medical authorization for one continuous week in the month prior to hospitalization;\n* 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\n* The patient and at least one family member were willing to participate.\n\nExclusion Criteria:\n\n* Patient on conservatorship or legal guardian status'}, 'identificationModule': {'nctId': 'NCT01125267', 'briefTitle': 'Promoting Adherence to Treatment in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Promoting Adherence to Treatment in Schizophrenia', 'orgStudyIdInfo': {'id': '5R01MH064542-05', 'link': 'https://reporter.nih.gov/quickSearch/5R01MH064542-05', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '5R01MH064542-05', 'link': 'https://reporter.nih.gov/quickSearch/5R01MH064542-05', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'multifamily group-adherence', 'description': 'multifamily group treatment with a focus on improving adherence to antipsychotic medication', 'interventionNames': ['Behavioral: multifamily group-adherence']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'multifamily group-standard', 'description': 'multifamily group focused on problems identified by group participants', 'interventionNames': ['Behavioral: multifamily group-standard']}, {'type': 'NO_INTERVENTION', 'label': 'treatment as usual'}], 'interventions': [{'name': 'multifamily group-adherence', 'type': 'BEHAVIORAL', 'description': 'multifamily groups held twice a month for one year focused on improving medication adherence using techniques derived from the Theory of Planned Behavior', 'armGroupLabels': ['multifamily group-adherence']}, {'name': 'multifamily group-standard', 'type': 'BEHAVIORAL', 'description': 'multifamily groups held twice a month focused on general problem solving method', 'armGroupLabels': ['multifamily group-standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91344', 'city': 'Granada Hills', 'state': 'California', 'country': 'United States', 'facility': 'San Fernando Mental Health Center', 'geoPoint': {'lat': 34.26472, 'lon': -118.52314}}], 'overallOfficials': [{'name': 'Alex J Kopelowicz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geffen School of Medicine at UCLA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Alex Kopelowicz, M.D.', 'oldOrganization': 'David Geffen School of Medicine at UCLA'}}}}