UV Exposure Assessed With Wearable Sensor and Sun Protection

Sun Protection Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03344796
• Other study ID #: STU00205910
• Secondary ID: R44CA224658
• Status: Completed
• Phase: N/A
• Start date: June 30, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: July 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Cohort Study 1:

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 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.

Related Conditions & MeSH terms

• Erythema
• Sun Protection
• Sunburn
• Sunburn, Erythema

Intervention

Behavioral:
• Goal attainment
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.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine Department of Dermatology	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Robinson JK, Durst DA, Gray E, Kwasny M, Heo SY, Banks A, Rogers JA. Sun exposure reduction by melanoma survivors with wearable sensor providing real-time UV exposure and daily text messages with structured goal setting. Arch Dermatol Res. 2021 Oct;313(8) — View Citation

Stump TK, Aspinwall LG, Gray EL, Xu S, Maganti N, Leachman SA, Alshurafa N, Robinson JK. Daily Minutes of Unprotected Sun Exposure (MUSE) Inventory: Measure description and comparisons to UVR sensor and sun protection survey data. Prev Med Rep. 2018 Jul 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant Reported Sunburns Prior to Intervention and During the Intervention	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.	56 days
Other	Knowledge of Sun Protection	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.	2 months
Primary	Acceptability of Wearing UV Sensor and Receiving Text Messages	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	cohort study 1 (arms 1 and 2) at end of 21 days, cohort study 2 (only one arm) at end of 28 days
Secondary	Sun Exposure in Participants With Structured vs Unstructured Goal Setting	Change in daily UV exposure recorded by UV sensor (J/m^2/day) between period prior to and after goal setting among melanoma survivors	21 days