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| Descriptive Information Fields | |||||||||
| Brief Title † | Improving Adherence to Oral Antipsychotic Medications in People With Schizophrenia | ||||||||
| Official Title † | Interventions for Adherence to Oral Antipsychotic Medications in Schizophrenia | ||||||||
| Brief Summary | This study will determine the comparative effectiveness of two systems designed to improve medication adherence in people with schizophrenia. |
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| Detailed Description | Schizophrenia is a severely debilitating mental disorder. People with schizophrenia often experience unusual thoughts or perceptions, decreased pleasure in everyday life, and difficulty functioning in social situations. Antipsychotic medications have been shown to be effective in improving the symptoms of schizophrenia. Poor adherence to medication, however, leads to re-hospitalization, impedes the process of recovery, and contributes to the high costs associated with schizophrenia treatment. Studies have shown that PharmCAT, cognitive adaptive training that specifically targets medication adherence, has been effective in improving adherence and outcomes in people with schizophrenia. The Med-eMonitor™ is a new pill device that is able to alert patients when they should take medication, when they are taking the wrong medication, and when they are taking medication at the wrong time. The device can also record side effect complaints and then send stored information to treatment staff. The capabilities of the Med-eMonitor™ eliminate the need for the weekly home visits that are necessary in the PharmCAT program, and may make treatment more easily available to individuals in remote or rural settings. This study will compare the effectiveness of PharmCAT, the Med-eMonitor™, and standard treatment in improving medication adherence and treatment outcome in people with schizophrenia. Participants in this study will be randomly assigned to one of the following treatment groups: (1) PharmCAT; (2) the Med-eMonitor™; or (3) standard treatment. Participants in Group 1 will receive weekly home visits from a case manager. These visits will specifically target medication adherence. Participants in Group 2 will use the Med-eMonitor™ device. Data recorded by the device will be sent electronically to study staff. Participants in Group 3 will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function. The device will record only when medication is taken. All participants will report to the study site at study entry and Months 4, 7, and 10 for measures of symptoms, functioning, social activities, and relationships. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Adherence [ Time Frame: Measured at Months 4, 7, and 10 and at Year 5 ] [ Designated as safety issue: No ] Social and Occupational Functioning Assessment Scale (SOFAS) scores [ Time Frame: Measured at Months 4, 7, and 10 and at Year 5 ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Schizophrenia symptoms [ Time Frame: Measured at Months 4, 7, and 10 and at Year 5 ] [ Designated as safety issue: No ] Functioning [ Time Frame: Measured at Months 4, 7, and 10 and at Year 5 ] [ Designated as safety issue: No ] Treatment outcome [ Time Frame: Measured at Months 4, 7, and 10 and at Year 5 ] [ Designated as safety issue: No ] |
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| Condition † | Schizophrenia Schizoaffective Disorder |
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| Intervention † | Device: Med-eMonitor Device Procedure: PharmCAT Therapy Behavioral: Standard treatment |
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| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 150 | ||||||||
| Start Date † | November 2006 | ||||||||
| Completion Date | July 2011 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00406718 | ||||||||
| Organization ID | R01 MH74047 | ||||||||
| Secondary IDs †† | DAHBR 96-BHA | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | February 2008 | ||||||||
| First Received Date † | November 30, 2006 | ||||||||
| Last Updated Date | February 29, 2008 | ||||||||