Using mHealth to Aid Opioid Medication Adherence Pilot Study

CareTeam Solutions

Status: Completed

Conditions: Opioid Dependence

Treatments: Device: Medsignals; Device: smartphone app

Study type: Observational

Funder types: Industry

Identifiers

NCT02017041

HHSN271201300015C (Other Grant/Funding Number)

HHSN271201300015C-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

9 participants in 1 patient group

buprenorphine/naloxone

Description:

Opioid substitution therapy patient taking buprenorphine/naloxone, MedSignals and smartphone app.

Treatment:

Device: Medsignals

Device: smartphone app