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临床试验/NCT00392236
NCT00392236已完成不适用

2-Way Pagers to Improve Schizophrenia Medication Adherence

Northwell Health1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2006年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Percent of Prescribed Medication Taken as Assessed by the Medication Event Monitoring System (MEMS)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
  • •Admitted to the Zucker Hillside Hospital for exacerbation of illness
  • •Speaks English

排除标准

  • •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

研究组 & 干预措施

A

Experimental

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

干预措施: 2-way pager (Device)

B

Active Comparator

Participants will receive treatment as usual

干预措施: Treatment as usual (Behavioral)

结局指标

主要结局

Percent of Prescribed Medication Taken as Assessed by the Medication Event Monitoring System (MEMS)

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Delbert Robinson

Professor of Psychiatry

National Institute of Mental Health (NIMH)

研究点 (1)

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