Improving Adherence to Oral Antipsychotic Medications in People With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      This study will determine the comparative effectiveness of two systems designed to improve
      medication adherence in people with schizophrenia.
    

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.
    

Intervention name(s): Med-eMonitor; PharmCAT; Treatment as Usual
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed.; Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.; Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Medication Adherence; Psychosocial Treatment; Cognitive Adaptation Training; Med-e Monitor; Adaptive Function