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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00057135 |
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Date of registration:
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27/03/2003 |
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Primary sponsor: |
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Public title:
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Improving Antipsychotic Adherence Among Patients With Serious Mental Illness
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Scientific title:
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Improving Antipsychotic Adherence Among Patients With Schizophrenia |
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Date of first enrolment:
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November 2002 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00057135 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Marcia T. Valenstein, MD AB |
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Address:
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Telephone:
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Email:
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Affiliation:
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VA Ann Arbor Healthcare System |
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Name:
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John Grabowski, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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VA Medical Center, Providence |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Patients must be adult veterans. Diagnosis of schizophrenia, schizoaffective disorder, or
bipolar disorder. At least one active oral antipsychotic prescription. History of poor
medication compliance.
Exclusion Criteria:
Have received depot antipsychotics in the last year. Have supervised medication
administration. Have not attended a VA outpatient appointment in the past 6 months, and
none are scheduled,. Are prescribed Clozapine. Have a fatal illness with a life
expectancy less than 2 years.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bipolar Disorder
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Schizoaffective Disorder
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Schizophrenia
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Intervention(s)
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Behavioral: Mailed reminders to patient when medication refills are due
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Behavioral: Note to Mental Health Provider when refill is overdue
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Behavioral: Unit of use medication packaging
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Procedure: Aligning all prescriptions to fall due on same date
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Primary Outcome(s)
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Medication Possession Ratio at baseline, 1-6 months, 6-12 months, and 12-18 months. Aggregate adherence categories based on MPR, anti-psychotic blood levels (present/not present) and patient self-report at baseline, 6 months, and 12 months.
[Time Frame: No]
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Secondary Outcome(s)
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Positive and Negative Syndrome Scale for Schizophrenia, Client Satisfaction Questionnaire, Quality of Well-Being Scale. All to be administered at baseline, 6 months, and 12 months after enrollment
[Time Frame: No]
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Secondary ID(s)
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IIR 01-074
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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