Mobile Health (mHealth) App for Safe Opioid Use

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-24

Study Completion Date

2022-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Participants Investigators

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

Study Groups

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Control

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

Group Type ACTIVE_COMPARATOR

Prescription Opioid Management App

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Prescription Opioid Management App

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Prescription Opioid Management App

Intervention Type DEVICE

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

Interventions

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Prescription Opioid Management App

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

Intervention Type DEVICE

Eligibility Criteria

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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