NCT01953237

Brief Summary

We propose to develop and pilot test the effect of a mobile smartphone intervention, MedActive, on improving antipsychotic adherence among individuals with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Sep 2013

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

September 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 19, 2016

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

September 25, 2013

Results QC Date

October 25, 2016

Last Update Submit

August 15, 2019

Conditions

Schizophrenia

Keywords

Schizophreniaantipsychotic medication adherencemobile phones

Outcome Measures

Primary Outcomes (1)

  • Adherence to Antipsychotic Medications

    A measure of the extent to which participants self-reported taking their antipsychotic medications as prescribed

    3 month period

Study Arms (2)

Control

ACTIVE COMPARATOR

Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.

Device: Smartphone

MedActive

EXPERIMENTAL

Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.

Behavioral: MedActive

Interventions

MedActiveBEHAVIORAL

Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.

MedActive
SmartphoneDEVICE
Control

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Decisional capacity to provide informed consent
  • Chart diagnosis of schizophrenia or schizoaffective disorder
  • Currently prescribed at least one oral antipsychotic medication
  • Self administers at least one oral antipsychotic medication
  • years of age
  • English Speaking
  • Be able to read English

You may not qualify if:

  • Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of mobile phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinics within the University of Maryland Division of Community Psychiatry

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Julie Kreyenbuhl
Organization
University of Maryland, Baltimore
jkreyenb@som.umaryland.edu
410-637-1864

Study Officials

  • Julie A Kreyenbuhl, Pharm.D PhD

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

September 25, 2013

First Posted

September 30, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

August 28, 2019

Results First Posted

December 19, 2016

Record last verified: 2019-08

Locations

US(1)