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Completed

NCT Number: NCT03344796

UV Exposure Assessed With Wearable Sensor and Sun Protection

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.

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Key information

Conditions

Sunburn, Erythema Burns Erythema Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Photosensitivity Disorders Signs and Symptoms Skin Diseases Skin Manifestations Skin Neoplasms Skin and Connective Tissue Diseases Sun Protection Sunburn Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Cohort Study 1:

Inclusion criteria

  • 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

Exclusion criteria

-

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.

Treatment and study plan

Goal attainment

Behavioral

After reviewing daily UV exposure in the prior 10 days, participants will be randomized to structured (select strategies from a list of 7 items) or unstructured (submit a free text description of a strategy) goal attainment.

Primary outcomes

  1. Acceptability of Wearing UV Sensor and Receiving Text Messages

    Time frame: 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

Secondary outcomes

  1. Sun Exposure in Participants With Structured vs Unstructured Goal Setting

    Time frame: 21 days

    Change in daily UV exposure recorded by UV sensor (J/m^2/day) between period prior to and after goal setting among melanoma survivors

Other outcomes

  1. Participant Reported Sunburns Prior to Intervention and During the Intervention

    Time frame: 56 days

    Young adult participants with sun sensitive skin reported sunburns in the 28 days prior to the intervention and during the 28 days of the intervention.

  2. Knowledge of Sun Protection

    Time frame: 2 months

    Knowledge of sun protection using the scale after completing focus group after completing an arm of the study. The same scale was administered at baseline for each arm.

    9 item scale (Minimum= 9, Maximum=18) Total range is 9-18. Higher value is better knowledge and a better outcome.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2017
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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