Improving Medication Adherence Among People With Schizophrenia Through the Use of 2-way Pagers

Study Overview
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Brief Summary
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This study will determine whether using a pager improves medication adherence in people with schizophrenia.

Detailed Description
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Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, and believe that others are controlling their thoughts. Many people with schizophrenia have difficulty with remembering their scheduled doctor's appointments and with taking their medication on time because of their mental illness. Many approved medications for schizophrenia must be taken several times a day and side effects such as drowsiness, dizziness, and even weight gain can deter a person from consistently taking their medication on time. Therefore, this study will determine whether a 2-way pager will help people with schizophrenia to remember their doctor's appointments and to take their medication on time. Participants in this open-label study will first complete several written tests to assess skills such as memory, attention, and problem solving. Participants will also be asked questions regarding their current symptoms and medication regimen. Participants will then be randomly assigned to receive either treatment as usual or treatment as usual and a 2-way pager for 6 months. Participants who receive a 2-way pager will attend approximately four information sessions. During these sessions, participants will learn how to program the pager and use a specially designed medication bottle cap that will record the number of bottle openings and the date and time of each opening. At designated times, the pager will vibrate or beep, alerting participants to take their medication or attend a scheduled appointment. All participants will meet weekly with a staff member for the first month and then once a month for the remaining 5 months to complete several brief questionnaires on pager use, assess medication adherence, and discuss any symptoms experienced within the past week or month. Participants will be required to bring their medication to each meeting to ensure compliance.

Official Title
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2-Way Pagers to Improve Schizophrenia Medication Adherence

Conditions
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Schizophrenia

Intervention / Treatment
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* Device: 2-way pager
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets DSM-IV criteria for schizophrenia or schizoaffective disorder Admitted to the Zucker Hillside Hospital for exacerbation of illness Speaks English Exclusion Criteria: Presence of severe visual or motor impairments Mental retardation Neurologic disorder that may impact functioning such as seizures or vascular, neoplastic, traumatic, or infectious disorders affecting the brain Prescribed a psychotropic drug in depot form After hospital discharge, a living or treatment situation that includes dispensing of full medication regimen

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Participants will receive treatment as usual and a 2-way pager for 6 months | Device: 2-way pager<br>* Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking.<br>|
| Active Comparator: B<br>Participants will receive treatment as usual | Behavioral: Treatment as usual<br>* Participants will receive treatment as usual.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Prescribed Medication Taken as Assessed by the Medication Event Monitoring System (MEMS) | Estimated percent of prescribed medication taken during month 6 of the study was calculated using all available data sources (MEMS supplemented by subject interview and pill counts). | Measured at Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizoaffective Disorder