Using mHealth to Aid Opioid Medication Adherence Pilot Study
2 other identifiers
observational
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2013
CompletedFirst Posted
Study publicly available on registry
December 20, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFebruary 3, 2015
February 1, 2015
5 months
December 9, 2013
February 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
questionnaire assessing usability of the system.
up to 5 weeks
Study Arms (1)
buprenorphine/naloxone
Opioid substitution therapy patient taking buprenorphine/naloxone, MedSignals and smartphone app.
Interventions
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.
The smartphone app being evaluated in this study is designed to support effective medication management of opioid substitution patients taking buprenorphine/naloxone.
Eligibility Criteria
community sample
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Care Team Solutions
Lexington, Kentucky, 40507, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Bailey, PhD
Care Team Solutions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2013
First Posted
December 20, 2013
Study Start
January 1, 2014
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
February 3, 2015
Record last verified: 2015-02