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Due to COVID the study couldn't be completed. Funds were returned to the funding agency.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points but there will be no reward provided. |
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| Contingency Management - Virtual Pet | Active Comparator | 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. |
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| Contingency Management - Monetary | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prescription Opioid Management App | Device | Smartphone application that provides education and reinforcement of safe opioid use, storage, and disposal |
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| Measure | Description | Time Frame |
|---|---|---|
| Device functionality | Confirmation that the app features work as intended based on user input | Assessed at the end of the one-week trial |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in knowledge quiz score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann D Bagchi, PhD,DNP | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Jersey Community Research Initiative | Newark | New Jersey | 07103 | United States |
There is no plan to share individual participant data
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Participants will enter all data using a numeric identifier assigned by a third-party recruiter
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 |