Using mHealth to Aid Opioid Medication Adherence Pilot Study

Completed

• Conditions: Opioid Dependence
• Interventions: Device: Medsignals; Device: smartphone app

• Registration Number: NCT02017041
• Lead Sponsor: Care Team Solutions

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-20
• Study Start: 2014-01
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
buprenorphine/naloxone	smartphone app	Opioid substitution therapy patient taking buprenorphine/naloxone, MedSignals and smartphone app.
buprenorphine/naloxone	Medsignals	Opioid substitution therapy patient taking buprenorphine/naloxone, MedSignals and smartphone app.

Primary Outcome Measures

Name	Time	Method
questionnaire assessing usability of the system.	up to 5 weeks

Trial Locations

Locations (1)

Care Team Solutions; 🇺🇸 Lexington, Kentucky, United States