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Clinical Trials/NCT02017041
NCT02017041
Completed
Not Applicable

Using mHealth to Aid Opioid Medication Adherence Pilot Study

Care Team Solutions1 site in 1 country9 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Dependence
Sponsor
Care Team Solutions
Enrollment
9
Locations
1
Primary Endpoint
questionnaire assessing usability of the system.
Status
Completed
Last Updated
11 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
June 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Care Team Solutions
Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

questionnaire assessing usability of the system.

Time Frame: up to 5 weeks

Study Sites (1)

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