NCT00392236

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

April 29, 2014

Completed
Last Updated

October 25, 2017

Status Verified

September 1, 2017

Enrollment Period

3.7 years

First QC Date

October 23, 2006

Results QC Date

March 10, 2014

Last Update Submit

September 22, 2017

Conditions

Keywords

Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

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

    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).

    Measured at Month 6

Study Arms (2)

A

EXPERIMENTAL

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

Device: 2-way pager

B

ACTIVE COMPARATOR

Participants will receive treatment as usual

Behavioral: Treatment as usual

Interventions

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.

A

Participants will receive treatment as usual.

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Delbert Robinson, M.D.
Organization
Feinstein Institute for Medical Research

Study Officials

  • Delbert G. Robinson, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

October 23, 2006

First Posted

October 25, 2006

Study Start

April 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 25, 2017

Results First Posted

April 29, 2014

Record last verified: 2017-09

Locations