Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals

Overview

OASIS: A mobile study to measure and predict lupus (SLE) disease activity using digital signals The OASIS study is exploring how patient reported data and digital biomarkers, like activity level and heart rate variability, can be used to predict changes in lupus disease activity. You may receive a Withings Steel HR smartwatch as part of this study. The purpose of this study is to look for factors that affect lupus disease activity and potentially predict lupus flares through non-clinical tests

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2020

Arms, Groups and Cohorts

  • Lupus Cases
    • Individuals who are diagnosed with System Lupus Erythematosus and consent to the study will be placed in this cohort. Upon enrollment they will be given the opportunity to invite a non-SLE-diagnosed friend to enroll in the study as a healthy control. These individuals will answer weekly questions and receive a smartwatch to measure their physical activity.

Clinical Trial Outcome Measures

Primary Measures

  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week two
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week three
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week four
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week five
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week six
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week seven
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week eight
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week nine
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week ten
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week eleven
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week twelve
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week thirteen
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week fourteen
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week fifteen
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week sixteen
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week seventeen
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week eighteen
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week nineteen
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week twenty
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week twenty-one
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week twenty-two
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week twenty-three
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week twenty-four
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week twenty-five
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • OASIS Wellness and Disease Questionnaire
    • Time Frame: Week twenty-six
    • Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
  • Short Form, 36 question form
    • Time Frame: Month one
    • 36 questions asking individuals questions about their general health and wellness, not disease-specific
  • Short Form, 36 question form
    • Time Frame: Month two
    • 36 questions asking individuals questions about their general health and wellness, not disease-specific
  • Short Form, 36 question form
    • Time Frame: Month three
    • 36 questions asking individuals questions about their general health and wellness, not disease-specific
  • Short Form, 36 question form
    • Time Frame: Month four
    • 36 questions asking individuals questions about their general health and wellness, not disease-specific
  • Short Form, 36 question form
    • Time Frame: Month five
    • 36 questions asking individuals questions about their general health and wellness, not disease-specific
  • Short Form, 36 question form
    • Time Frame: Month six
    • 36 questions asking individuals questions about their general health and wellness, not disease-specific
  • Withings Heartrate & Activity
    • Time Frame: Continuously, for six months
    • Patient activity, sleep quality, and heart rate collected by the wearable watch

Secondary Measures

  • Heart rate variability
    • Time Frame: Week two
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week three
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week four
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week five
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week six
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week seven
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week eight
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week nine
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week ten
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week eleven
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week twelve
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week thirteen
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week fourteen
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week fifteen
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week sixteen
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week seventeen
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week eighteen
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week nineteen
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week twenty
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week twenty-one
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week twenty-two
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week twenty-three
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week twenty-four
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week twenty-five
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera
  • Heart rate variability
    • Time Frame: Week twenty-six
    • Measurement of individual’s change in pulse via a smartphone’s onboard camera

Participating in This Clinical Trial

Inclusion Criteria

  • Female or male age 18 or older – Participant is currently not enrolled in another study – Able to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures Exclusion Criteria:

  • NOT able to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures – Known to be pregnant

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Progentec Diagnostics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eldon Jupe, Ph.D., Principal Investigator, Progentec Diagnostics
  • Overall Contact(s)
    • Eldon Jupe, Ph.D., 4052164818, ejupe@progentec.com

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