Clinical trial NCT00406718: Improving Adherence to Oral Antipsychotic Medications in People With Schizophrenia
Official title: Interventions for Adherence to Oral Antipsychotic Medications in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Medication Adherence
Psychosocial Treatment
Cognitive Adaptation Training
Med-e Monitor
Adaptive Function
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2006-12-04
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adherence
timeFrame: Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)
measure: Social and Occupational Functioning Assessment Scale (SOFAS) Scores
timeFrame: Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)
Secondary outcomes:
measure: Schizophrenia Symptoms
timeFrame: Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio (UTHSCSA)
name: Dawn I. Velligan, PhD
role: PRINCIPAL_INVESTIGATOR
References: