Using mHealth to Aid Opioid Medication Adherence Pilot Study

February 2, 2015 updated by: Care Team Solutions
The purpose of this study is to evaluate the usability of an interactive smartphone application (app) designed to engage and support patients receiving bup/nal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the usability of a medication management aid for opioid dependence named SubAID. The SubAID system is a smartphone application and medication monitor designed to optimize adherence behaviors of an OD patient responsible for administering bup/nal maintenance therapy medication.

Usability of the SubAID system will be tested utilizing a 3-Stage study design over a 5 week period among a cohort of subjects prescribed bup/nal and undergoing OST.

  • Stage 1 - 1 week: Participants will use only an electronic medication monitor (MedSignals) in control mode to passively record baseline adherence to medication.
  • Stage 2 - 2 weeks: Participants will use MedSignals in control mode and the smartphone application.
  • Stage 3 - 2 weeks: Participants will use MedSignals in active mode and the smartphone application.

After each stage usability assessments will be conducted to evaluate satisfaction with the products from participants.

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40507
        • Care Team Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

community sample

Description

Inclusion Criteria:

  • At least 21 years of age
  • Physician diagnosis of opioid dependence (OD)
  • Prescribed buprenorphine/naloxone (bup/nal) and acclimated to medication.
  • Able to speak and read English
  • Willing to provide written informed consent prior to study entry
  • Able to understand the study
  • Ownership of an Android or iPhone smartphone

Exclusion Criteria:

  • Having any concurrent medical or psychiatric condition that, in the investigator's opinion, may preclude participation in this study; or
  • Cognitive or other impairment that would interfere with completing a self-administered questionnaire.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
buprenorphine/naloxone
Opioid substitution therapy patient taking buprenorphine/naloxone, MedSignals and smartphone app.
Device: Medsignals
MedSignals (www.medsignals.com) is a cellular communicating medication management device designed to improve adherence. It will be used to track when medication is removed from the device at dosing times and deliver audible and visual alerts at dosing times and to relay adherence data securely to patient files. Participants will use this device throughout the 5-week trial. It is a Class I device.
Device: smartphone app
The smartphone app being evaluated in this study is designed to support effective medication management of opioid substitution patients taking buprenorphine/naloxone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
questionnaire assessing usability of the system.
Time Frame: up to 5 weeks
up to 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Care Team Solutions

Investigators

  • Study Director: Michael Bailey, PhD, Care Team Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Estimate)

February 3, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHSN271201300015C-1
  • HHSN271201300015C (Other Grant/Funding Number: National Institute on Drug Abuse (NIDA/NIH))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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