Improving Adherence to Oral Antipsychotic Medications in People With Schizophrenia - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00406718

Purpose

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

Condition	Intervention
Schizophrenia Schizoaffective Disorder	Device: Med-eMonitor Device Procedure: PharmCAT Therapy Behavioral: Standard treatment

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Interventions for Adherence to Oral Antipsychotic Medications in Schizophrenia

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Adherence [ Time Frame: Measured at Months 4, 7, and 10 and at Year 5 ] [ Designated as safety issue: No ]
Social and Occupational Functioning Assessment Scale (SOFAS) scores [ Time Frame: Measured at Months 4, 7, and 10 and at Year 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Schizophrenia symptoms [ Time Frame: Measured at Months 4, 7, and 10 and at Year 5 ] [ Designated as safety issue: No ]
Functioning [ Time Frame: Measured at Months 4, 7, and 10 and at Year 5 ] [ Designated as safety issue: No ]
Treatment outcome [ Time Frame: Measured at Months 4, 7, and 10 and at Year 5 ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	November 2006
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive PharmCAT	Procedure: PharmCAT Therapy 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.
2: Active Comparator Participants will receive the Med-eMonitor™	Device: Med-eMonitor Device 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.
3: Active Comparator Participants will receive standard treatment	Behavioral: Standard treatment Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function.

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

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406718

Contacts

Contact: Natalie J. Maples, MA	210-562-5250	maplesn@uthscsa.edu
Contact: Monica Mery	210-562-5253

Locations

United States, Texas
The University of Texas Health Science Center at San Antonio	Recruiting
San Antonio, Texas, United States, 78207

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Dawn I. Velligan, PhD

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

More Information

Responsible Party:	UTHSCSA ( Dawn I. Velligan, PhD )
Study ID Numbers:	R01 MH74047, DAHBR 96-BHA
Study First Received:	November 30, 2006
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00406718
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Medication Adherence
Psychosocial Treatment
Cognitive Adaptation Training
Med-e Monitor
Adaptive Function

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 30, 2009