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

• Conditions: Lupus Erythematosus; Lupus Erythematosus, Systemic

• Registration Number: NCT04449653
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-28
• Study First Submitted: 2020-05-26
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-23
• Last Update Submitted: 2020-06-23
• Study First Posted: 2020-06-29
• Last Update Posted: 2020-06-29
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OASIS Wellness and Disease Questionnaire	Week twenty-six	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Short Form, 36 question form	Month six	36 questions asking individuals questions about their general health and wellness, not disease-specific
Withings Heartrate & Activity	Continuously, for six months	Patient activity, sleep quality, and heart rate collected by the wearable watch

Secondary Outcome Measures

Name	Time	Method
Heart rate variability	Week twenty-six	Measurement of individual's change in pulse via a smartphone's onboard camera

Trial Locations

Locations (1)

Ryan Newhardt; 🇺🇸 Oklahoma City, Oklahoma, United States