Using mHealth to Aid Opioid Medication Adherence Pilot Study

Opioid Dependence Clinical Trial

Official title:

Using mHealth to Aid Opioid Medication Adherence Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017041
• Other study ID #: HHSN271201300015C-1
• Secondary ID: HHSN271201300015
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: February 2, 2015
• Start date: January 2014
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: Care Team Solutions
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

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.
• smartphone app
The smartphone app being evaluated in this study is designed to support effective medication management of opioid substitution patients taking buprenorphine/naloxone.

Locations

Country	Name	City	State
United States	Care Team Solutions	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Care Team Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	questionnaire assessing usability of the system.		up to 5 weeks	No