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

Lupus Erythematosus, Systemic Clinical Trial

— OASIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04449653
• Other study ID #: MEASURE
• Status: Recruiting
• Start date: April 28, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2020
• Source: Progentec Diagnostics, Inc.
• Contact: Eldon Jupe, Ph.D.
• Phone: 4052164818
• Email: ejupe[@]progentec.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus
• Lupus Erythematosus, Systemic

Locations

Country	Name	City	State
United States	Ryan Newhardt	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Progentec Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	OASIS Baseline Questionnaire	Basic Health Information and SLE-specific questions	Baseline, entered only upon enrollment
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week two
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week three
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week four
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week five
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week six
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week seven
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week eight
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week nine
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week ten
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week eleven
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week twelve
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week thirteen
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week fourteen
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week fifteen
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week sixteen
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week seventeen
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week eighteen
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week nineteen
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week twenty
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week twenty-one
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week twenty-two
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week twenty-three
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week twenty-four
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week twenty-five
Primary	OASIS Wellness and Disease Questionnaire	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week	Week twenty-six
Primary	Short Form, 36 question form	36 questions asking individuals questions about their general health and wellness, not disease-specific	Month one
Primary	Short Form, 36 question form	36 questions asking individuals questions about their general health and wellness, not disease-specific	Month two
Primary	Short Form, 36 question form	36 questions asking individuals questions about their general health and wellness, not disease-specific	Month three
Primary	Short Form, 36 question form	36 questions asking individuals questions about their general health and wellness, not disease-specific	Month four
Primary	Short Form, 36 question form	36 questions asking individuals questions about their general health and wellness, not disease-specific	Month five
Primary	Short Form, 36 question form	36 questions asking individuals questions about their general health and wellness, not disease-specific	Month six
Primary	Withings Heartrate & Activity	Patient activity, sleep quality, and heart rate collected by the wearable watch	Continuously, for six months
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week two
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week three
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week four
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week five
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week six
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week seven
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week eight
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week nine
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week ten
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week eleven
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week twelve
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week thirteen
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week fourteen
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week fifteen
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week sixteen
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week seventeen
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week eighteen
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week nineteen
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week twenty
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week twenty-one
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week twenty-two
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week twenty-three
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week twenty-four
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week twenty-five
Secondary	Heart rate variability	Measurement of individual's change in pulse via a smartphone's onboard camera	Week twenty-six