Improving Adherence to Oral Antipsychotic Medications in People With Schizophrenia

NCT00406718 | Completed Results

• 1 other identifier: R01MH074047
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Adherence

  Adherence derived from electronic monitoring. Percentage of medication taken during each preceding 3 month period, averaged across treatment period.

  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)

• Social and Occupational Functioning Assessment Scale (SOFAS) Scores

  Scale from 1-100 rating global social and occupational functioning. Higher scores indicate better functional outcomes

  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 (1)

• Schizophrenia Symptoms

  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)

Study Arms (3)

PharmCAT

EXPERIMENTAL

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.

Behavioral: PharmCAT

Med-eMonitor

ACTIVE COMPARATOR

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.

Behavioral: Med-eMonitor

Treatment as Usual

ACTIVE COMPARATOR

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

Behavioral: Treatment as Usual

Interventions

Med-eMonitor 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.

Med-eMonitor

PharmCAT 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.

PharmCAT

Treatment as Usual 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.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78207, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Medication Adherence

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Patients had long-standing illness and results may not apply to patients with a more recent onset of schizophrenia/schizoaffective disorder

Results Point of Contact

• Title: Dr. Dawn Velligan
• Organization: UT_SanAntonio UTHSCSA

velligand@uthscsa.edu

210-567-5508

Study Officials

• Dawn I. Velligan, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor Department of Psychiatry

Study Record Dates

• First Submitted: November 30, 2006
• First Posted: December 4, 2006
• Study Start: November 1, 2006
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 5, 2015
• Results First Posted: October 5, 2015

Record last verified: 2015-07

Locations

US (1)