Mobile Health (mHealth) App for Safe Opioid Use

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04462250

Collaborator

(none)

Enrollment

Location

Arms

21.2

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use	Device: Prescription Opioid Management App	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Participants will enter all data using a numeric identifier assigned by a third-party recruiter

Primary Purpose:

Device Feasibility

Official Title:

Development of a Mobile Health App to Improve the Safe Use, Storage, and Disposal of Opioid Medications

Actual Study Start Date :

Aug 24, 2020

Anticipated Primary Completion Date :

Feb 28, 2022

Anticipated Study Completion Date :

May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points but there will be no reward provided.	Device: Prescription Opioid Management App Smartphone application that provides education and reinforcement of safe opioid use, storage, and disposal
Active Comparator: Contingency Management - Virtual Pet 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.	Device: Prescription Opioid Management App Smartphone application that provides education and reinforcement of safe opioid use, storage, and disposal
Active Comparator: Contingency Management - Monetary 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.	Device: Prescription Opioid Management App Smartphone application that provides education and reinforcement of safe opioid use, storage, and disposal

Arm

Intervention/Treatment

Active Comparator: Control

Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points but there will be no reward provided.

Device: Prescription Opioid Management App

Smartphone application that provides education and reinforcement of safe opioid use, storage, and disposal

Active Comparator: Contingency Management - Virtual Pet

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.

Device: Prescription Opioid Management App

Smartphone application that provides education and reinforcement of safe opioid use, storage, and disposal

Active Comparator: Contingency Management - Monetary

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.

Device: Prescription Opioid Management App

Smartphone application that provides education and reinforcement of safe opioid use, storage, and disposal

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Jersey Community Research Initiative	Newark	New Jersey	United States	07103

Sponsors and Collaborators

Rutgers, The State University of New Jersey

Investigators

Principal Investigator: Ann D Bagchi, PhD,DNP, Rutgers, The State University of New Jersey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ann D. Bagchi, PhD, DNP, Assistant Professor, Rutgers, The State University of New Jersey

ClinicalTrials.gov Identifier:

NCT04462250

Other Study ID Numbers:

Pro2020001699

First Posted:

Jul 8, 2020

Last Update Posted:

Sep 27, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Analgesics, Opioid

Study Results

No Results Posted as of Sep 27, 2021