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

Northwell Health55 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

2-way pagerDEVICE

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.

Treatment as usualBEHAVIORAL

Participants will receive treatment as usual.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Zucker Hillside Hospital

Glen Oaks, New York, United States

Outcomes

Primary Outcomes

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).

Time frame: Measured at Month 6

Data from ClinicalTrials.gov

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