Using mHealth to Aid Opioid Medication Adherence Pilot Study

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.

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Key information

Conditions

Opioid Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Care Team Solutions

Lexington, Kentucky, 40507, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medsignals

Device

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.

Smartphone APP

Device

The smartphone app being evaluated in this study is designed to support effective medication management of opioid substitution patients taking buprenorphine/naloxone.

Primary outcomes

questionnaire assessing usability of the system.

Time frame: up to 5 weeks

Sponsors and collaborators

Lead sponsor

Care Team Solutions

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Dec 20, 2013
Registry last updated: Feb 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed