Clinical trial NCT04449653: Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals
Official title: Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lupus Erythematosus, Systemic
Lupus Erythematosus
Keywords: Lupus
SLE
Lead sponsor: Progentec Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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


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

Primary outcomes:
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week two
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week three
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week four
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week five
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week six
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week seven
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week eight
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week nine
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week ten
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week eleven
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week twelve
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week thirteen
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week fourteen
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week fifteen
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week sixteen
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week seventeen
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week eighteen
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week nineteen
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week twenty
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week twenty-one
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week twenty-two
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week twenty-three
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week twenty-four
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week twenty-five
measure: OASIS Wellness and Disease Questionnaire
timeFrame: Week twenty-six
measure: Short Form, 36 question form
timeFrame: Month one
measure: Short Form, 36 question form
timeFrame: Month two
measure: Short Form, 36 question form
timeFrame: Month three
measure: Short Form, 36 question form
timeFrame: Month four
measure: Short Form, 36 question form
timeFrame: Month five
measure: Short Form, 36 question form
timeFrame: Month six
measure: Withings Heartrate & Activity
timeFrame: Continuously, for six months
Secondary outcomes:
measure: Heart rate variability
timeFrame: Week two
measure: Heart rate variability
timeFrame: Week three
measure: Heart rate variability
timeFrame: Week four
measure: Heart rate variability
timeFrame: Week five
measure: Heart rate variability
timeFrame: Week six
measure: Heart rate variability
timeFrame: Week seven
measure: Heart rate variability
timeFrame: Week eight
measure: Heart rate variability
timeFrame: Week nine
measure: Heart rate variability
timeFrame: Week ten
measure: Heart rate variability
timeFrame: Week eleven
measure: Heart rate variability
timeFrame: Week twelve
measure: Heart rate variability
timeFrame: Week thirteen
measure: Heart rate variability
timeFrame: Week fourteen
measure: Heart rate variability
timeFrame: Week fifteen
measure: Heart rate variability
timeFrame: Week sixteen
measure: Heart rate variability
timeFrame: Week seventeen
measure: Heart rate variability
timeFrame: Week eighteen
measure: Heart rate variability
timeFrame: Week nineteen
measure: Heart rate variability
timeFrame: Week twenty
measure: Heart rate variability
timeFrame: Week twenty-one
measure: Heart rate variability
timeFrame: Week twenty-two
measure: Heart rate variability
timeFrame: Week twenty-three
measure: Heart rate variability
timeFrame: Week twenty-four
measure: Heart rate variability
timeFrame: Week twenty-five
measure: Heart rate variability
timeFrame: Week twenty-six
Other outcomes:
measure: OASIS Baseline Questionnaire
timeFrame: Baseline, entered only upon enrollment
Locations:
city: Oklahoma City
country: United States
facility: Ryan Newhardt
state: Oklahoma
Study officials:
affiliation: Progentec Diagnostics
name: Eldon Jupe, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: