Using mHealth to Aid Opioid Medication Adherence Pilot Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02017041|
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : February 3, 2015
|Condition or disease||Intervention/treatment|
|Opioid Dependence||Device: Medsignals Device: smartphone app|
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|
|Actual Enrollment :||9 participants|
|Official Title:||Using mHealth to Aid Opioid Medication Adherence Pilot Study|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Opioid substitution therapy patient taking buprenorphine/naloxone, MedSignals and smartphone app.
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.
- questionnaire assessing usability of the system. [ Time Frame: up to 5 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017041
|United States, Kentucky|
|Care Team Solutions|
|Lexington, Kentucky, United States, 40507|
|Study Director:||Michael Bailey, PhD||Care Team Solutions|