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

Progentec Diagnostics, Inc.300 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Lupus Erythematosus, Systemic Lupus Erythematosus

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ryan Newhardt

Oklahoma City, Oklahoma, United States

RECRUITING

Outcomes

Primary Outcomes

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week two

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week three

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week four

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week five

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week six

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week seven

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week eight

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Central Contacts

Eldon Jupe, Ph.D.

CONTACT

4052164818 ejupe@progentec.com

Ryan Newhardt, B.S.

CONTACT

4052130605 rnewhardt@progentec.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: Week nine

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week ten

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week eleven

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week twelve

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week thirteen

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week fourteen

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week fifteen

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week sixteen

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week seventeen

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week eighteen

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week nineteen

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week twenty

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week twenty-one

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week twenty-two

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week twenty-three

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week twenty-four

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week twenty-five

OASIS Wellness and Disease Questionnaire

Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week

Time frame: Week twenty-six

Short Form, 36 question form

36 questions asking individuals questions about their general health and wellness, not disease-specific

Time frame: Month one

Short Form, 36 question form

36 questions asking individuals questions about their general health and wellness, not disease-specific

Time frame: Month two

Short Form, 36 question form

36 questions asking individuals questions about their general health and wellness, not disease-specific

Time frame: Month three

Short Form, 36 question form

36 questions asking individuals questions about their general health and wellness, not disease-specific

Time frame: Month four

Short Form, 36 question form

36 questions asking individuals questions about their general health and wellness, not disease-specific

Time frame: Month five

Short Form, 36 question form

36 questions asking individuals questions about their general health and wellness, not disease-specific

Time frame: Month six

Withings Heartrate & Activity

Patient activity, sleep quality, and heart rate collected by the wearable watch

Time frame: Continuously, for six months