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Clinical Trials/NCT04462250
NCT04462250
Withdrawn
N/A

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

Rutgers, The State University of New Jersey1 site in 1 country15 target enrollmentAugust 24, 2020

Overview

Phase
N/A
Intervention
Prescription Opioid Management App
Conditions
Opioid Use
Sponsor
Rutgers, The State University of New Jersey
Enrollment
15
Locations
1
Primary Endpoint
Device functionality
Status
Withdrawn
Last Updated
16 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 24, 2020
End Date
February 28, 2021
Last Updated
16 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ann D. Bagchi, PhD, DNP

Assistant Professor

Rutgers, The State University of New Jersey

Eligibility Criteria

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

Arms & Interventions

Control

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

Intervention: Prescription Opioid Management App

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.

Intervention: Prescription Opioid Management App

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.

Intervention: Prescription Opioid Management App

Outcomes

Primary Outcomes

Device functionality

Time Frame: Assessed at the end of the one-week trial

Confirmation that the app features work as intended based on user input

Secondary Outcomes

  • Mobile App Rating Scale (MARS)(Data collected through app and telephone interviews at the end of the one-week trial)
  • Change in knowledge quiz score(Change in score as assessed at the end of the one-week trial)

Study Sites (1)

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