Trials / Completed
CompletedNCT02017041
Using mHealth to Aid Opioid Medication Adherence Pilot Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 9 (actual)
- Sponsor
- Care Team Solutions · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2014-06-01
- Completion
- 2014-06-01
- First posted
- 2013-12-20
- Last updated
- 2015-02-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02017041. Inclusion in this directory is not an endorsement.