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Improving Medication Adherence Among People With Schizophrenia Through the Use of 2-way Pagers
This study is ongoing, but not recruiting participants.
Study NCT00392236   Information provided by National Institute of Mental Health (NIMH)
First Received: October 23, 2006   Last Updated: September 25, 2009   History of Changes

October 23, 2006
September 25, 2009
April 2006
December 2009   (final data collection date for primary outcome measure)
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 ]
Percent of prescribed doses taken as measured by the Medication Event Monitoring System (MEMS)
Complete list of historical versions of study NCT00392236 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Multidimensional Scale of Independent Functioning
  • Drug Attitude Inventory
  • Positive and Negative Symptom Scale
  • Self Appraisal of Illness Questionnaire
  • Quality of Life Interview (Short Version)
 
Improving Medication Adherence Among People With Schizophrenia Through the Use of 2-way Pagers
2-Way Pagers to Improve Schizophrenia Medication Adherence

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.

 
Interventional
Supportive Care, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Schizophrenia
  • Device: 2-way pager
  • Behavioral: Treatment as usual
  • Experimental: Participants will receive treatment as usual and a 2-way pager for 6 months
  • Active Comparator: Participants will receive treatment as usual
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
80
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00392236
Delbert Robinson, North Shore-Long Island Jewish Health System
R34 MH074844, DAHBR 96-BHA
National Institute of Mental Health (NIMH)
 
Principal Investigator: Delbert G. Robinson, MD North Shore Long Island Jewish Health System
National Institute of Mental Health (NIMH)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP