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Using mHealth to Aid Opioid Medication Adherence Pilot Study

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ClinicalTrials.gov Identifier: NCT02017041
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Opioid Dependence Device: Medsignals Device: smartphone app

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 Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. questionnaire assessing usability of the system. [ Time Frame: up to 5 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
community sample
Criteria

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.

Information from the National Library of Medicine

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


Locations
United States, Kentucky
Care Team Solutions
Lexington, Kentucky, United States, 40507
Sponsors and Collaborators
Care Team Solutions
Investigators
Study Director: Michael Bailey, PhD Care Team Solutions

Responsible Party: Care Team Solutions
ClinicalTrials.gov Identifier: NCT02017041     History of Changes
Other Study ID Numbers: HHSN271201300015C-1
HHSN271201300015C ( Other Grant/Funding Number: National Institute on Drug Abuse (NIDA/NIH) )
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: February 2015

Keywords provided by Care Team Solutions:
opioid dependence, buprenorphine, smartphone, suboxone

Additional relevant MeSH terms:
Analgesics, Opioid
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists