Mobile Health (mHealth) App for Safe Opioid Use

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04462250
• Other study ID #: Pro2020001699
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 24, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: September 2021
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: May 31, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use

Intervention

Device:
• Prescription Opioid Management App
Smartphone application that provides education and reinforcement of safe opioid use, storage, and disposal

Locations

Country	Name	City	State
United States	North Jersey Community Research Initiative	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device functionality	Confirmation that the app features work as intended based on user input	Assessed at the end of the one-week trial
Secondary	Mobile App Rating Scale (MARS)	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	Data collected through app and telephone interviews at the end of the one-week trial
Secondary	Change in knowledge quiz score	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	Change in score as assessed at the end of the one-week trial