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临床试验/NCT04462250
NCT04462250撤回不适用

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

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年8月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
15
试验地点
1
主要终点
Device functionality

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Device Feasibility
盲法
Double (Participant, Investigator)

盲法说明

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Unable to provide informed consent
  • Pregnant women
  • Currently being treated for/history of mental health or substance use disorder

研究组 & 干预措施

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.

干预措施: Prescription Opioid Management App (Device)

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.

干预措施: Prescription Opioid Management App (Device)

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.

干预措施: Prescription Opioid Management App (Device)

结局指标

主要结局

Device functionality

时间窗: Assessed at the end of the one-week trial

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ann D. Bagchi, PhD, DNP

Assistant Professor

Rutgers, The State University of New Jersey

研究点 (1)

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