Improving Adherence to Oral Antipsychotic Medications in People With Schizophrenia

Tracking Information
First Submitted Date ICMJE	November 30, 2006
First Posted Date ICMJE	December 4, 2006
Results First Submitted Date	May 1, 2015
Results First Posted Date	October 5, 2015
Last Update Posted Date	October 5, 2015
Study Start Date ICMJE	November 2006
Actual Primary Completion Date	July 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 1, 2015)	Adherence [ Time Frame: 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) ]Adherence derived from electronic monitoring. Percentage of medication taken during each preceding 3 month period, averaged across treatment period.; Social and Occupational Functioning Assessment Scale (SOFAS) Scores [ Time Frame: 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) ]Scale from 1-100 rating global social and occupational functioning. Higher scores indicate better functional outcomes
Original Primary Outcome Measures ICMJE; (submitted: November 30, 2006)	Measured at Months 4, 7, and 10: Adherence; Social and Occupational Functioning Assessment Scale (SOFAS) scores
Change History	Complete list of historical versions of study NCT00406718 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 1, 2015)	Schizophrenia Symptoms [ Time Frame: 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) ]; Brief Psychiatric Rating Scale (BPRS) expanded version psychosis subscale, mean of items for unusual thought content, auspiciousness, conceptual disorganization, and hallucinations. Higher scores mean greater level of symptomatology. Scores vary from 1 = absent to 7 = severe
Original Secondary Outcome Measures ICMJE; (submitted: November 30, 2006)	Measured at Months 4, 7, and 10: Schizophrenia symptoms; Functioning; Treatment outcome
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Improving Adherence to Oral Antipsychotic Medications in People With Schizophrenia
Official Title ICMJE	Interventions for Adherence to Oral Antipsychotic Medications in Schizophrenia
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Schizophrenia; Schizoaffective Disorder
Intervention ICMJE	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.
Study Arms	Experimental: 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. Intervention: Behavioral: PharmCAT; Active Comparator: 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. Intervention: Behavioral: Med-eMonitor; Active Comparator: Treatment as Usual Participants will receive standard treatment as usual which is medication management and limited case management provided by the CMHC. Intervention: Behavioral: Treatment as Usual
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 1, 2015)	197
Original Enrollment ICMJE; (submitted: November 30, 2006)	150
Actual Study Completion Date	July 2013
Actual Primary Completion Date	July 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 60 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00406718
Other Study ID Numbers ICMJE	R01MH074047( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Dawn Velligan, The University of Texas Health Science Center at San Antonio
Study Sponsor ICMJE	The University of Texas Health Science Center at San Antonio
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Dawn I. Velligan, PhD The University of Texas Health Science Center at San Antonio (UTHSCSA)
PRS Account	The University of Texas Health Science Center at San Antonio
Verification Date	July 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP