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

• ClinicalTrials.gov Identifier: NCT00392236
• Recruitment Status: Completed
• First Posted: October 25, 2006
• Results First Posted: April 29, 2014
• Last Update Posted: October 25, 2017
• Sponsor: Northwell Health
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Delbert Robinson, National Institute of Mental Health (NIMH)

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Device: 2-way pager; Behavioral: Treatment as usual	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: 2-Way Pagers to Improve Schizophrenia Medication Adherence
• Study Start Date: April 2006
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: December 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: A; 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.
Active Comparator: B; Participants will receive treatment as usual	Behavioral: Treatment as usual; Participants will receive treatment as usual.

Outcome Measures

Primary Outcome Measures :

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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, New York

The Zucker Hillside Hospital

Glen Oaks, New York, United States, 11004

Sponsors and Collaborators

Northwell Health

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Delbert G. Robinson, MD; Northwell Health

More Information

• Responsible Party: Delbert Robinson, Professor of Psychiatry, National Institute of Mental Health (NIMH)
• ClinicalTrials.gov Identifier: NCT00392236
• Other Study ID Numbers: R34MH074844 ( U.S. NIH Grant/Contract ); R34MH074844 ( U.S. NIH Grant/Contract )
• First Posted: October 25, 2006
• Results First Posted: April 29, 2014
• Last Update Posted: October 25, 2017
• Last Verified: September 2017

Keywords provided by Delbert Robinson, National Institute of Mental Health (NIMH):

Schizoaffective Disorder

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders