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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| OASIS Baseline Questionnaire | Basic Health Information and SLE-specific questions | Baseline, entered only upon enrollment |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eldon Jupe, Ph.D. | Contact | 4052164818 | 3 | ejupe@progentec.com |
| Ryan Newhardt, B.S. | Contact | 4052130605 | rnewhardt@progentec.com |
| Name | Affiliation | Role |
|---|---|---|
| Eldon Jupe, Ph.D. | Progentec Diagnostics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ryan Newhardt | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| 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 |
| 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 |