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UV Exposure Assessed With Wearable Sensor and Sun Protection

Primary Purpose

Sunburn, Erythema, Sun Protection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Goal attainment
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sunburn, Erythema focused on measuring Skin Cancer, Sunburn, erythema, UV Exposure, Sunburn, Wearable UV Device

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Northwestern University Feinberg School of Medicine Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

No Intervention

Active Comparator

No Intervention

No Intervention

Active Comparator

Arm Label

Focus Group

Usability testing

Cohort Study 1-Arm 1

Structured Interviews

Cohort Study 2

Cohort Study 1- Arm 2

Arm Description

32 subjects Focus group: It is expected that each participant will provide comments during the 2 hours of the focus group. It will take about one month to enroll the subjects. The audio files should be transcribed and the analysis completed in 60 days. The analysis will determine enablers and barriers to sun protected outdoor activities and determine strategies for achieving sun protected outdoor activities. Baseline knowledge of sun protection performed prior to and at end of focus group.

10 subjects Usability test with structured interview: Each participant will use the sensor for 14 days and transmit data with the app installed on their mobile phone. It will take about one month to enroll the subjects. The analysis of the structured interview is completed in one week. Baseline knowledge of sun protection performed prior to and at end of usability test.

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.

20 young adults, ages 18-39 will participate in structured interviews to determine their barriers and enablers of sun exposure and sun protection. Eligible subjects will have at least one hour a day outdoors with 30 minutes of the hour being consecutive. It will take about 3 months to enroll the subjects. The audio files will be transcribed and analysis completed in 60 days. Baseline knowledge of sun protection will be performed prior to and after structured interviews.

Second cohort study: 42 young adult participants will recall the number of sunburns experienced in the 28 days prior to enrolling in the study. Then, the same young adult participants will wear the UV sensor daily for 28 summer days. Participants will receive a warning on their mobile phone if the UV dose approaches the dose anticipated to cause sunburn in unprotected skin. Participants will record the number of days in which they get a sunburn. Baseline knowledge of sun protection performed prior to and at end of study.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 26, 2017
Last Updated
July 5, 2023
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03344796
Brief Title
UV Exposure Assessed With Wearable Sensor and Sun Protection
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 30, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sunburn, Erythema, Sun Protection
Keywords
Skin Cancer, Sunburn, erythema, UV Exposure, Sunburn, Wearable UV Device

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cohort study 1 is parallel and randomized Cohort Study 2 is a single group study with comparison of the participants' reported sunburns prior to intervention and during the intervention
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
cohort study 1 and 2 were masked. Each participant was identified by a study number assigned in REDCap
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Focus Group
Arm Type
No Intervention
Arm Description
32 subjects Focus group: It is expected that each participant will provide comments during the 2 hours of the focus group. It will take about one month to enroll the subjects. The audio files should be transcribed and the analysis completed in 60 days. The analysis will determine enablers and barriers to sun protected outdoor activities and determine strategies for achieving sun protected outdoor activities. Baseline knowledge of sun protection performed prior to and at end of focus group.
Arm Title
Usability testing
Arm Type
No Intervention
Arm Description
10 subjects Usability test with structured interview: Each participant will use the sensor for 14 days and transmit data with the app installed on their mobile phone. It will take about one month to enroll the subjects. The analysis of the structured interview is completed in one week. Baseline knowledge of sun protection performed prior to and at end of usability test.
Arm Title
Cohort Study 1-Arm 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Structured Interviews
Arm Type
No Intervention
Arm Description
20 young adults, ages 18-39 will participate in structured interviews to determine their barriers and enablers of sun exposure and sun protection. Eligible subjects will have at least one hour a day outdoors with 30 minutes of the hour being consecutive. It will take about 3 months to enroll the subjects. The audio files will be transcribed and analysis completed in 60 days. Baseline knowledge of sun protection will be performed prior to and after structured interviews.
Arm Title
Cohort Study 2
Arm Type
No Intervention
Arm Description
Second cohort study: 42 young adult participants will recall the number of sunburns experienced in the 28 days prior to enrolling in the study. Then, the same young adult participants will wear the UV sensor daily for 28 summer days. Participants will receive a warning on their mobile phone if the UV dose approaches the dose anticipated to cause sunburn in unprotected skin. Participants will record the number of days in which they get a sunburn. Baseline knowledge of sun protection performed prior to and at end of study.
Arm Title
Cohort Study 1- Arm 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Goal attainment
Intervention Description
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 Outcome Measure Information:
Title
Acceptability of Wearing UV Sensor and Receiving Text Messages
Description
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
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
Secondary Outcome Measure Information:
Title
Sun Exposure in Participants With Structured vs Unstructured Goal Setting
Description
Change in daily UV exposure recorded by UV sensor (J/m^2/day) between period prior to and after goal setting among melanoma survivors
Time Frame
21 days
Other Pre-specified Outcome Measures:
Title
Participant Reported Sunburns Prior to Intervention and During the Intervention
Description
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.
Time Frame
56 days
Title
Knowledge of Sun Protection
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
June K. Robinson, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33185716
Citation
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):685-694. doi: 10.1007/s00403-020-02163-1. Epub 2020 Nov 13.
Results Reference
result
PubMed Identifier
30116702
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 24;11:305-311. doi: 10.1016/j.pmedr.2018.07.010. eCollection 2018 Sep.
Results Reference
result
PubMed Identifier
33955844
Citation
Robinson JK, Patel S, Heo SY, Gray E, Lim J, Kwon K, Christiansen Z, Model J, Trueb J, Banks A, Kwasny M, Rogers JA. Real-Time UV Measurement With a Sun Protection System for Warning Young Adults About Sunburn: Prospective Cohort Study. JMIR Mhealth Uhealth. 2021 May 6;9(5):e25895. doi: 10.2196/25895.
Results Reference
derived

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UV Exposure Assessed With Wearable Sensor and Sun Protection

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