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临床试验/NCT04530591
NCT04530591已完成不适用

A Proof of Concept, Randomized, Single Center Study on Frameworks for Wearable Devices to Sense and Respond to Opioid Overdoses

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2020年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
97
试验地点
1
主要终点
Community Need for a Device-based Opioid Overdose Intervention

研究概览

简要总结

This pilot study evaluates the needs of opioid users for a device-based intervention for opioid overdoses. The results of this one-time short questionnaire will inform development of a novel naloxone delivery device.

详细描述

All opioid overdose related deaths can be prevented with the timely delivery of Naloxone. This study is a one-time, preliminary survey of participants with opioid use disorder to assess the need for, and community attitudes towards, a wearable device capable of autonomously detecting and responding to an opioid overdose. The results of this survey will be used to guide ongoing development of a de novo device. This study will be conducted over a 3 month period and survey participants from the Kensington Neighborhood in North Philadelphia.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Have used opioids for more than 3 months or will be having surgery where opioids will be administered
  • Able to provide informed consent
  • Moderate to severe chronic pain treated with opioids or recreational use

排除标准

  • Pregnancy

结局指标

主要结局

Community Need for a Device-based Opioid Overdose Intervention

时间窗: Day 1

We aim to characterize the degree of need for a device-based opioid overdose intervention. These were extracted from the participant survey questions as well as from the words, phrases, and sentences used by participants during the interview.

次要结局

  • Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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