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

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 Overview

• Status: Unknown
• Conditions: Lupus Erythematosus, Systemic; Lupus Erythematosus

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Eldon Jupe, Ph.D.; Phone Number: 3 4052164818; Email: ejupe@progentec.com
• Study Contact Backup: Name: Ryan Newhardt, B.S.; Phone Number: 4052130605; Email: rnewhardt@progentec.com

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • Ryan Newhardt
      • Contact: Ryan Newhardt, B.S.; Phone Number: 405-213-0605; Email: rnewhardt@progentec.com
      • Principal Investigator: Eldon Jupe, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
OASIS Baseline Questionnaire	Basic Health Information and SLE-specific questions	Baseline, entered only upon enrollment

Collaborators and Investigators

• Sponsor: Progentec Diagnostics, Inc.
• Investigators: Principal Investigator: Eldon Jupe, Ph.D., Progentec Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Lupus; SLE
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: MEASURE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No