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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2-way pager
Treatment as usual
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring Schizoaffective Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Zucker Hillside Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

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

Participants will receive treatment as usual

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
October 23, 2006
Last Updated
September 22, 2017
Sponsor
Northwell Health
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00392236
Brief Title
Improving Medication Adherence Among People With Schizophrenia Through the Use of 2-way Pagers
Official Title
2-Way Pagers to Improve Schizophrenia Medication Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizoaffective Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Participants will receive treatment as usual and a 2-way pager for 6 months
Arm Title
B
Arm Type
Active Comparator
Arm Description
Participants will receive treatment as usual
Intervention Type
Device
Intervention Name(s)
2-way pager
Intervention Description
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
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Participants will receive treatment as usual.
Primary Outcome Measure Information:
Title
Percent of Prescribed Medication Taken as Assessed by the Medication Event Monitoring System (MEMS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delbert G. Robinson, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States

12. IPD Sharing Statement

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

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