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

NCT ID: NCT00392236

Last Updated: 2017-10-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-12-31

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.

Conditions

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Schizophrenia

Keywords

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Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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A

Participants will receive treatment as usual and a 2-way pager for 6 months

Group Type EXPERIMENTAL

2-way pager

Intervention Type DEVICE

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.

B

Participants will receive treatment as usual

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

Participants will receive treatment as usual.

Interventions

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2-way pager

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.

Intervention Type DEVICE

Treatment as usual

Participants will receive treatment as usual.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Delbert Robinson

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Delbert G. Robinson, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

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The Zucker Hillside Hospital

Glen Oaks, New York, United States

Site Status

Countries

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United States

Other Identifiers

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R34MH074844

Identifier Type: NIH

Identifier Source: secondary_id

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R34MH074844

Identifier Type: NIH

Identifier Source: org_study_id

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