Schizophrenia Clinical Trial
Official title:
Interventions for Adherence to Oral Antipsychotic Medications in Schizophrenia
This study will determine the comparative effectiveness of two systems designed to improve medication adherence in people with schizophrenia.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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