跳至主要内容
临床试验/NCT03344796
NCT03344796已完成不适用

A Real-time, Cost-effective, Accurate UV Measurement and Sun Protection System to Prevent and Reduce the Incidence of Sunburn in High-risk Consumers

Northwestern University2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2018年6月30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
164
试验地点
2
主要终点
Acceptability of Wearing UV Sensor and Receiving Text Messages

研究概览

简要总结

The goal is to prevent ultraviolet light (UV) overexposure by providing consumers with relevant, easy-to-access, specifically actionable information. This research proposal will develop a UV protection system consisting of an automated real-time counseling framework and a personal dosimeter that overcomes barriers to consumer adoption. These new, wearable sensors take the form of small (< 1 cm), thin (<0.1 mm), lightweight (<0.1 g), battery-free "stickers" that are fundamentally differentiated from other wearable electronics in their modes of use, cost structures and accuracy.

详细描述

The proposed work is to refine and validate a UV protection system based on a dosimeter "sticker." The key innovations of the system are automated personalized intervention messaging triggered by the exposure levels measured by a novel charge accumulation device applied to ultraminiaturized circuit forms. The research will validate the system's accuracy and acceptability to users, refine the device, and prove its robustness and efficacy in real world use cases. Focus groups and structured interviews will develop sun protection strategies to be communicated by text messages to participants. Successful completion of the research will yield a system to prevent excessive UV exposure and sunburn, thus reducing the incidence of skin cancer by equipping large numbers of general-population consumers and at-risk people to practice digitally-informed healthy sun behavior.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

cohort study 1 and 2 were masked. Each participant was identified by a study number assigned in REDCap

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • history of Stage 0 to IIB melanoma treated within the last five years, age 18-70 years old
  • have a smartphone
  • familiarity with use of mobile apps
  • have skin type 1-3
  • willing to wear the sensor and able to transmit data which requires Wi-Fi in the home
  • Come to the Chicago campus of the medical school

排除标准

  • Cohort Study 2: Young adults with sun sensitive skin
  • Inclusion Criteria:
  • history of sun sensitive skin, skin type 1-3
  • have a smartphone and willing to use the UV guard application on the smartphone
  • reliable wireless internet connection to complete daily surveys
  • willing to wear the sensor for 28 days and transmit data and complete daily surveys
  • willing to receive SMS text messages on their personal phone and potentially sync sensor to personal phone using Bluetooth
  • If weather permits, person will spend at least one hour outdoors each day, with at least 30 minutes of that hour being consecutive between the hours of 8 AM and 5 PM
  • Exclusion Criteria:
  • unable to speak English
  • lacking a secure Internet connection or very little experience with smartphones and mobile applications .
  • unable to walk inside and outside independently
  • unable to be outdoors for at least one hour each day (weather permitting)
  • unable to be outdoors for 30 consecutive minutes a day between 8 AM and 5 PM.

结局指标

主要结局

Acceptability of Wearing UV Sensor and Receiving Text Messages

时间窗: cohort study 1 (arms 1 and 2) at end of 21 days, cohort study 2 (only one arm) at end of 28 days

Online system usability 6 item scale (Likert 7 items range from strongly disagree to strongly agree Minimum value 6, maximum value 42, higher score better outcome

次要结局

  • Sun Exposure in Participants With Structured vs Unstructured Goal Setting(21 days)

研究者

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

June Robinson

Primary Investigator

Northwestern University

研究点 (2)

Loading locations...

相似试验