Clinical trial NCT00392236: Improving Medication Adherence Among People With Schizophrenia Through the Use of 2-way Pagers
Official title: 2-Way Pagers to Improve Schizophrenia Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizoaffective Disorder
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-10-25
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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 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

Primary outcomes:
measure: Percent of Prescribed Medication Taken as Assessed by the Medication Event Monitoring System (MEMS)
timeFrame: Measured at Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Delbert G. Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References: