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Completed

NCT Number: NCT00392236

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2-way pager

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.

Treatment as Usual

Behavioral

Participants will receive treatment as usual.

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

2-Way Pagers to Improve Schizophrenia Medication Adherence

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 25, 2006
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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