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Improving Medication Adherence Among People With Schizophrenia Through the Use of 2-Way Pagers
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), September 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00392236
  Purpose

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


Condition Intervention
Schizophrenia
Device: 2-way pager
Behavioral: Treatment as usual

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title: 2-Way Pagers to Improve Schizophrenia Medication Adherence

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Percent of prescribed doses taken as assessed by the Medication Event Monitoring System (MEMS) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Multidimensional Scale of Independent Functioning [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
  • Drug Attitude Inventory [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
  • Brief Psychiatric Rating Scale (BPRS) and Modified Scale for the Assessment of Negative Symptoms (SANS) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
  • Self Appraisal of Illness Questionnaire [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
  • Quality of Life Interview (Short Version) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2006
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
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.
B: Active Comparator
Participants will receive treatment as usual
Behavioral: Treatment as usual
Participants will receive treatment as usual.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392236

Contacts
Contact: Cristina Gomes, BA 718-470-8975 cgomes@lij.edu
Contact: Priya Matneja, BA 718-470-8953 pmatneja@lij.edu

Locations
United States, New York
The Zucker Hillside Hospital Recruiting
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
Investigators
Principal Investigator: Delbert G. Robinson, MD North Shore Long Island Jewish Health System
  More Information

Responsible Party: North Shore-Long Island Jewish Health System ( Delbert Robinson )
Study ID Numbers: R34 MH074844, DAHBR 96-BHA
Study First Received: October 23, 2006
Last Updated: September 10, 2008
ClinicalTrials.gov Identifier: NCT00392236  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Schizoaffective Disorder

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 30, 2009