Mobile Health (mHealth) App for Safe Opioid Use

Rutgers The State University of New Jersey

Status: Unknown

Conditions: Opioid Use

Treatments: Device: Prescription Opioid Management App

Study type: Interventional

Funder types: Other

Identifiers

NCT04462250

Pro2020001699

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 3 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Device: Prescription Opioid Management App

Contingency Management - Virtual Pet

Active Comparator group

Description:

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.

Treatment:

Device: Prescription Opioid Management App

Contingency Management - Monetary

Active Comparator group

Description:

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.

Treatment:

Device: Prescription Opioid Management App