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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00392236
Recruitment Status : Completed
First Posted : October 25, 2006
Results First Posted : April 29, 2014
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Delbert Robinson, National Institute of Mental Health (NIMH)

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

Condition or disease Intervention/treatment Phase
Schizophrenia Device: 2-way pager Behavioral: Treatment as usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 2-Way Pagers to Improve Schizophrenia Medication Adherence
Study Start Date : April 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: A
Participants will receive treatment as usual and a 2-way pager for 6 months
Device: 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.

Active Comparator: B
Participants will receive treatment as usual
Behavioral: Treatment as usual
Participants will receive treatment as usual.




Primary Outcome Measures :
  1. Percent of Prescribed Medication Taken as Assessed by the Medication Event Monitoring System (MEMS) [ Time Frame: Measured at Month 6 ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392236


Locations
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United States, New York
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
Northwell Health
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Delbert G. Robinson, MD Northwell Health
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Responsible Party: Delbert Robinson, Professor of Psychiatry, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00392236    
Other Study ID Numbers: R34MH074844 ( U.S. NIH Grant/Contract )
R34MH074844 ( U.S. NIH Grant/Contract )
First Posted: October 25, 2006    Key Record Dates
Results First Posted: April 29, 2014
Last Update Posted: October 25, 2017
Last Verified: September 2017
Keywords provided by Delbert Robinson, National Institute of Mental Health (NIMH):
Schizoaffective Disorder
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders