NCT00406718

Improving Adherence to Oral Antipsychotic Medications in People With Schizophrenia

Interventions for Adherence to Oral Antipsychotic Medications in Schizophrenia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Med-eMonitor	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.
BEHAVIORAL	PharmCAT	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.
BEHAVIORAL	Treatment as Usual	Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function.

Timeline

• Start date: 2006-11-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2006-12-04
• Last updated: 2015-10-05
• Results posted: 2015-10-05

Locations

1 site across 1 country: United States