Mobile Health (mHealth) App for Safe Opioid Use

Not Applicable

• Conditions: Opioid Use
• Interventions: Device: Prescription Opioid Management App

• Registration Number: NCT04462250
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

A key driver of the current opioid overdose epidemic is the misuse of legitimately prescribed opioid medications. Patient education through use of mobile technology may help to increase knowledge of appropriate use of opioid medications; however, knowledge does not always translate into behavior modification. Therefore, there is a need for more research into patient-facing technology that can increase both knowledge and behaviors consistent with appropriate opioid use. These needs have been amplified by the severe acute respiratory syndrome coronavirus-2 (COVID-19) pandemic, which has exposed healthcare disparities, heightened the risk for mental and behavioral health disorders, and dramatically increased reliance on telehealth technologies. It is critically important that telehealth solutions be accessible and user-friendly for all consumers, particularly members of underserved communities with limited digital health literacy. This feasibility study will develop a mobile health app to improve appropriate use of opioid medications among patients with a prescription to treat non-cancer pain. The study will use focus groups with consumers and providers to determine the content and features to be included in the app and will test the feasibility of implementing a contingency management approach (i.e., rewards system) with the app using a randomized control trial. The key outcome of interest is confirmation of the design and operating specifications of the app, including the use of contingency management. Secondary outcomes of interest are the overall rating of the app and an increase in knowledge among users regarding the safe use, storage, and disposal of opioid medications.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-08
• Study Start: 2020-08-24
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-27
• Primary Completion: 2022-02-28
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Has current prescription for opioid medication
• Any ethnic group
• Served through the following programs of partnering organization: primary medical care, transgender medical care, HIV and sexually transmitted infection (STI) screening and counseling, LGBTQ services, pre-exposure prophylaxis and post exposure prophylaxis services, health education, clinical research, case management, psychosocial services, nutrition counseling, treatment adherence
• Owns an Android-base smartphone

Exclusion Criteria

• Unable to provide informed consent
• Pregnant women
• Currently being treated for/history of mental health or substance use disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contingency Management - Virtual Pet	Prescription Opioid Management App	Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points, which can be used in the care of a virtual pet.
Contingency Management - Monetary	Prescription Opioid Management App	Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points, which will be paid out at the end of the one-week trial in the form of a monetary reward.
Control	Prescription Opioid Management App	Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points but there will be no reward provided.

Primary Outcome Measures

Name	Time	Method
Device functionality	Assessed at the end of the one-week trial	Confirmation that the app features work as intended based on user input

Secondary Outcome Measures

Name	Time	Method
Mobile App Rating Scale (MARS)	Data collected through app and telephone interviews at the end of the one-week trial	Participants' assessment of functionality and utility of app with 19 items scored from 1 to 5 (overall score range 19 to 95) where higher scores indicate better app rating
Change in knowledge quiz score	Change in score as assessed at the end of the one-week trial	Participants will show an increase in knowledge related to the safe used, storage, and disposal of opioid medications based on a 10-item, investigator created, pre/post quiz (total score range of 1 to 10) designed to address key educational components of the app

Trial Locations

Locations (1)

North Jersey Community Research Initiative; 🇺🇸 Newark, New Jersey, United States