Improving Adherence to Oral Antipsychotic Medications in People With Schizophrenia

NCT ID: NCT00406718

Last Updated: 2015-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2013-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PharmCAT

Participants will receive PharmCAT in addition to Treatment as usual, 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.

Group Type: EXPERIMENTAL

PharmCAT

Intervention Type: BEHAVIORAL

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.

Med-eMonitor

Participants will receive Med-eMonitor™ in addition to treatment as usual. 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.

Group Type: ACTIVE_COMPARATOR

Med-eMonitor

Intervention Type: BEHAVIORAL

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.

Treatment as Usual

Participants will receive standard treatment as usual which is medication management and limited case management provided by the CMHC.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV criteria, as determined on the basis of the Structured Clinical Interview for Diagnosis (SCID-P)
• Receiving treatment with an oral atypical antipsychotic medication other than clozapine (e.g., risperidone, olanzapine, quetiapine, aripiprazole, ziprasidone, or others as they are FDA approved)
• Assumes some responsibility for taking own medications
• Able to provide evidence of a stable living environment (e.g., individual apartment, family home, or board and care facility) within 3 months prior to study entry and no plans to move in the next year
• Intact visual and auditory ability as determined by a computerized screening battery
• Ability to read at the 5th grade level or higher based upon score on the Wide Range Achievement Test (WRAT)
• Able to understand and complete rating scales and neuropsychological testing
• Working telephone present in the home

Exclusion Criteria

• History of significant head trauma, seizure disorder, or mental retardation
• Alcohol or drug abuse or dependence within 3 months prior to study entry
• Currently being treated by an assertive community treatment (ACT) team
• History of violence within 1 year prior to study entry
• Any hospitalizations within 3 months prior to study entry

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Dawn Velligan

Clinical Professor Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn I. Velligan, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio (UTHSCSA)

Locations

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Countries

United States

Other Identifiers

R01MH074047

Identifier Type: NIH

Identifier Source: org_study_id

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