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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04449653
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Progentec Diagnostics, Inc.

Brief Summary:
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

Condition or disease
Lupus Erythematosus, Systemic Lupus Erythematosus

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 1, 2021

Group/Cohort
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.



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. Short Form, 36 question form [ Time Frame: Month one ]
    36 questions asking individuals questions about their general health and wellness, not disease-specific

  27. Short Form, 36 question form [ Time Frame: Month two ]
    36 questions asking individuals questions about their general health and wellness, not disease-specific

  28. Short Form, 36 question form [ Time Frame: Month three ]
    36 questions asking individuals questions about their general health and wellness, not disease-specific

  29. Short Form, 36 question form [ Time Frame: Month four ]
    36 questions asking individuals questions about their general health and wellness, not disease-specific

  30. Short Form, 36 question form [ Time Frame: Month five ]
    36 questions asking individuals questions about their general health and wellness, not disease-specific

  31. Short Form, 36 question form [ Time Frame: Month six ]
    36 questions asking individuals questions about their general health and wellness, not disease-specific

  32. Withings Heartrate & Activity [ Time Frame: Continuously, for six months ]
    Patient activity, sleep quality, and heart rate collected by the wearable watch


Secondary Outcome Measures :
  1. Heart rate variability [ Time Frame: Week two ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  2. Heart rate variability [ Time Frame: Week three ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  3. Heart rate variability [ Time Frame: Week four ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  4. Heart rate variability [ Time Frame: Week five ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  5. Heart rate variability [ Time Frame: Week six ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  6. Heart rate variability [ Time Frame: Week seven ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  7. Heart rate variability [ Time Frame: Week eight ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  8. Heart rate variability [ Time Frame: Week nine ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  9. Heart rate variability [ Time Frame: Week ten ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  10. Heart rate variability [ Time Frame: Week eleven ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  11. Heart rate variability [ Time Frame: Week twelve ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  12. Heart rate variability [ Time Frame: Week thirteen ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  13. Heart rate variability [ Time Frame: Week fourteen ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  14. Heart rate variability [ Time Frame: Week fifteen ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  15. Heart rate variability [ Time Frame: Week sixteen ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  16. Heart rate variability [ Time Frame: Week seventeen ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  17. Heart rate variability [ Time Frame: Week eighteen ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  18. Heart rate variability [ Time Frame: Week nineteen ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  19. Heart rate variability [ Time Frame: Week twenty ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  20. Heart rate variability [ Time Frame: Week twenty-one ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  21. Heart rate variability [ Time Frame: Week twenty-two ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  22. Heart rate variability [ Time Frame: Week twenty-three ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  23. Heart rate variability [ Time Frame: Week twenty-four ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  24. Heart rate variability [ Time Frame: Week twenty-five ]
    Measurement of individual's change in pulse via a smartphone's onboard camera

  25. Heart rate variability [ Time Frame: Week twenty-six ]
    Measurement of individual's change in pulse via a smartphone's onboard camera


Other Outcome Measures:
  1. OASIS Baseline Questionnaire [ Time Frame: Baseline, entered only upon enrollment ]
    Basic Health Information and SLE-specific questions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Lupus is more common by 3.5-fold among minority groups, e.g., African Americans, than it is among European- Americans.Additionally more than 90% of diagnosed cases of lupus are women. We anticipate significant enrollment of female gender and minority populations reflecting this racial and disparity in disease occurrence rates. Participants will be enrolled from across the United States, with no specific geographic locations being targeted or preferred.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04449653


Contacts
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Contact: Eldon Jupe, Ph.D. 4052164818 ext 3 ejupe@progentec.com
Contact: Ryan Newhardt, B.S. 4052130605 rnewhardt@progentec.com

Locations
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United States, Oklahoma
Ryan Newhardt Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Ryan Newhardt, B.S.    405-213-0605    rnewhardt@progentec.com   
Principal Investigator: Eldon Jupe, Ph.D.         
Sponsors and Collaborators
Progentec Diagnostics, Inc.
Investigators
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Principal Investigator: Eldon Jupe, Ph.D. Progentec Diagnostics
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Responsible Party: Progentec Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT04449653    
Other Study ID Numbers: MEASURE
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Progentec Diagnostics, Inc.:
Lupus
SLE
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases