<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04449653</url>
  </required_header>
  <id_info>
    <org_study_id>MEASURE</org_study_id>
    <nct_id>NCT04449653</nct_id>
  </id_info>
  <brief_title>Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals</brief_title>
  <acronym>OASIS</acronym>
  <official_title>Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Progentec Diagnostics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Progentec Diagnostics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      OASIS: A mobile study to measure and predict lupus (SLE) disease activity using digital&#xD;
      signals The OASIS study is exploring how patient reported data and digital biomarkers, like&#xD;
      activity level and heart rate variability, can be used to predict changes in lupus disease&#xD;
      activity. You may receive a Withings Steel HR smartwatch as part of this study. The purpose&#xD;
      of this study is to look for factors that affect lupus disease activity and potentially&#xD;
      predict lupus flares through non-clinical tests&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 28, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week two</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week three</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week four</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week five</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week six</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week seven</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week eight</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week nine</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week ten</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week eleven</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week twelve</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week thirteen</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week fourteen</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week fifteen</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week sixteen</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week seventeen</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week eighteen</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week nineteen</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week twenty</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week twenty-one</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week twenty-two</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week twenty-three</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week twenty-four</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week twenty-five</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OASIS Wellness and Disease Questionnaire</measure>
    <time_frame>Week twenty-six</time_frame>
    <description>Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Form, 36 question form</measure>
    <time_frame>Month one</time_frame>
    <description>36 questions asking individuals questions about their general health and wellness, not disease-specific</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Form, 36 question form</measure>
    <time_frame>Month two</time_frame>
    <description>36 questions asking individuals questions about their general health and wellness, not disease-specific</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Form, 36 question form</measure>
    <time_frame>Month three</time_frame>
    <description>36 questions asking individuals questions about their general health and wellness, not disease-specific</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Form, 36 question form</measure>
    <time_frame>Month four</time_frame>
    <description>36 questions asking individuals questions about their general health and wellness, not disease-specific</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Form, 36 question form</measure>
    <time_frame>Month five</time_frame>
    <description>36 questions asking individuals questions about their general health and wellness, not disease-specific</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Form, 36 question form</measure>
    <time_frame>Month six</time_frame>
    <description>36 questions asking individuals questions about their general health and wellness, not disease-specific</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Withings Heartrate &amp; Activity</measure>
    <time_frame>Continuously, for six months</time_frame>
    <description>Patient activity, sleep quality, and heart rate collected by the wearable watch</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week two</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week three</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week four</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week five</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week six</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week seven</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week eight</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week nine</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week ten</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week eleven</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week twelve</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week thirteen</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week fourteen</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week fifteen</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week sixteen</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week seventeen</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week eighteen</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week nineteen</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week twenty</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week twenty-one</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week twenty-two</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week twenty-three</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week twenty-four</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week twenty-five</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Week twenty-six</time_frame>
    <description>Measurement of individual's change in pulse via a smartphone's onboard camera</description>
  </secondary_outcome>
  <other_outcome>
    <measure>OASIS Baseline Questionnaire</measure>
    <time_frame>Baseline, entered only upon enrollment</time_frame>
    <description>Basic Health Information and SLE-specific questions</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Lupus Erythematosus, Systemic</condition>
  <condition>Lupus Erythematosus</condition>
  <arm_group>
    <arm_group_label>Lupus Cases</arm_group_label>
    <description>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.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Lupus is more common by 3.5-fold among minority groups, e.g., African Americans, than it is&#xD;
        among European- Americans.Additionally more than 90% of diagnosed cases of lupus are women.&#xD;
        We anticipate significant enrollment of female gender and minority populations reflecting&#xD;
        this racial and disparity in disease occurrence rates. Participants will be enrolled from&#xD;
        across the United States, with no specific geographic locations being targeted or&#xD;
        preferred.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female or male age 18 or older&#xD;
&#xD;
          -  Participant is currently not enrolled in another study&#xD;
&#xD;
          -  Able to understand the requirements of the study, provide written informed consent,&#xD;
             including consent for the use and disclosure of research-related health information,&#xD;
             and comply with the study data collection procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NOT able to understand the requirements of the study, provide written informed&#xD;
             consent, including consent for the use and disclosure of research-related health&#xD;
             information, and comply with the study data collection procedures&#xD;
&#xD;
          -  Known to be pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eldon Jupe, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Progentec Diagnostics</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eldon Jupe, Ph.D.</last_name>
    <phone>4052164818</phone>
    <phone_ext>3</phone_ext>
    <email>ejupe@progentec.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ryan Newhardt, B.S.</last_name>
    <phone>4052130605</phone>
    <email>rnewhardt@progentec.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ryan Newhardt</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ryan Newhardt, B.S.</last_name>
      <phone>405-213-0605</phone>
      <email>rnewhardt@progentec.com</email>
    </contact>
    <investigator>
      <last_name>Eldon Jupe, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lupus</keyword>
  <keyword>SLE</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04449653
org study id: MEASURE
nct id: NCT04449653
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
observational model: Case-Control
time perspective: Prospective
measure: OASIS Wellness and Disease Questionnaire
time frame: Week two
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week three
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week four
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week five
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week six
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week seven
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week eight
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week nine
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week ten
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week eleven
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week twelve
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week thirteen
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week fourteen
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week fifteen
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week sixteen
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week seventeen
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week eighteen
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week nineteen
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week twenty
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week twenty-one
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week twenty-two
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week twenty-three
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week twenty-four
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week twenty-five
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: OASIS Wellness and Disease Questionnaire
time frame: Week twenty-six
description: Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
measure: Short Form, 36 question form
time frame: Month one
description: 36 questions asking individuals questions about their general health and wellness, not disease-specific
measure: Short Form, 36 question form
time frame: Month two
description: 36 questions asking individuals questions about their general health and wellness, not disease-specific
measure: Short Form, 36 question form
time frame: Month three
description: 36 questions asking individuals questions about their general health and wellness, not disease-specific
measure: Short Form, 36 question form
time frame: Month four
description: 36 questions asking individuals questions about their general health and wellness, not disease-specific
measure: Short Form, 36 question form
time frame: Month five
description: 36 questions asking individuals questions about their general health and wellness, not disease-specific
measure: Short Form, 36 question form
time frame: Month six
description: 36 questions asking individuals questions about their general health and wellness, not disease-specific
measure: Withings Heartrate & Activity
time frame: Continuously, for six months
description: Patient activity, sleep quality, and heart rate collected by the wearable watch
measure: Heart rate variability
time frame: Week two
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week three
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week four
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week five
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week six
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week seven
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week eight
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week nine
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week ten
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week eleven
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week twelve
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week thirteen
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week fourteen
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week fifteen
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week sixteen
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week seventeen
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week eighteen
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week nineteen
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week twenty
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week twenty-one
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week twenty-two
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week twenty-three
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week twenty-four
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week twenty-five
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: Heart rate variability
time frame: Week twenty-six
description: Measurement of individual's change in pulse via a smartphone's onboard camera
measure: OASIS Baseline Questionnaire
time frame: Baseline, entered only upon enrollment
description: Basic Health Information and SLE-specific questions
arm group label: Lupus Cases
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Eldon Jupe, Ph.D.
role: Principal Investigator
affiliation: Progentec Diagnostics
last name: Eldon Jupe, Ph.D.
phone: 4052164818
phone ext: 3
email: ejupe@progentec.com
last name: Ryan Newhardt, B.S.
phone: 4052130605
email: rnewhardt@progentec.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Lupus Erythematosus, Systemic