Clinical trial NCT04462250: Mobile Health (mHealth) App for Safe Opioid Use
Official title: Development of a Mobile Health App to Improve the Safe Use, Storage, and Disposal of Opioid Medications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Use
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.


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

Primary outcomes:
measure: Device functionality
timeFrame: Assessed at the end of the one-week trial
Secondary outcomes:
measure: Mobile App Rating Scale (MARS)
timeFrame: Data collected through app and telephone interviews at the end of the one-week trial
measure: Change in knowledge quiz score
timeFrame: Change in score as assessed at the end of the one-week trial
Other outcomes:
Locations:
city: Newark
country: United States
facility: North Jersey Community Research Initiative
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Ann D Bagchi, PhD,DNP
role: PRINCIPAL_INVESTIGATOR
References: