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

Study Overview
=================
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

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

Conditions
-----------------
Lupus Erythematosus, Systemic, Lupus Erythematosus

Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lupus Cases<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SLE, Lupus