UV Exposure Assessed With Wearable Sensor and Sun Protection

Not Applicable

Completed

• Conditions: Sunburn, Erythema; Sun Protection
• Interventions: Behavioral: Goal attainment

• Registration Number: NCT03344796
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-11-13
• Study First Posted: 2017-11-17
• Study Start: 2018-06-30
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Results First Submitted: 2022-10-27
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-05
• Last Update Submitted: 2023-07-05
• Results First Posted: 2023-07-27
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

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

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Exclusion Criteria

Cohort Study 2: Young adults with sun sensitive skin

Inclusion Criteria:

1. history of sun sensitive skin, skin type 1-3
2. have a smartphone and willing to use the UV guard application on the smartphone
3. reliable wireless internet connection to complete daily surveys
4. willing to wear the sensor for 28 days and transmit data and complete daily surveys
5. willing to receive SMS text messages on their personal phone and potentially sync sensor to personal phone using Bluetooth
6. 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:

1. unable to speak English
2. lacking a secure Internet connection or very little experience with smartphones and mobile applications .
3. unable to walk inside and outside independently
4. unable to be outdoors for at least one hour each day (weather permitting)
5. unable to be outdoors for 30 consecutive minutes a day between 8 AM and 5 PM.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort Study 1- Arm 2	Goal attainment	29 subjects will receive daily text messages in a sequence starting with behavioral facilitation, outcome expectancies, self-efficacy, and self-regulation. On day 10, participants will receive a text message prompting review and reflection on the prior 10 days of UV exposure. Participants will be randomized in Arm 2 to submit a free text description of their strategy (unstructured goal attainment). Baseline knowledge of sun protection performed prior to and at end of intervention.
Cohort Study 1-Arm 1	Goal attainment	31 subjects First cohort study: It is expected that melanoma survivors will wear the sensor and transmit data for 21 days in the warm weather months of June-Aug 2019. It will take about 2 months to enroll the subjects. Subjects will receive daily text messages in a sequence starting with behavioral facilitation, outcome expectancies, self-efficacy, and self-regulation. On day 10, participants will receive a text message prompting review and reflection on the prior 10 days of UV exposure. Participants will be randomized in Arm 1 to receive a survey item inviting selection of strategies to achieve sun-protected outdoor activities (structured goal attainment). Baseline knowledge of sun protection performed prior to and at end of intervention.

Primary Outcome Measures

Name	Time	Method
Acceptability of Wearing UV Sensor and Receiving Text Messages	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 Outcome Measures

Name	Time	Method
Sun Exposure in Participants With Structured vs Unstructured Goal Setting	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

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine Department of Dermatology; 🇺🇸 Chicago, Illinois, United States