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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04449653

Acronym

OASIS

Enrollment

300

Registered

2020-06-29

Start date

2020-04-28

Completion date

2021-06-01

Last updated

2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Erythematosus, Lupus Erythematosus, Systemic

Keywords

Lupus, SLE

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
OASIS Wellness and Disease Questionnaire	Week two	Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Short Form, 36 question form	Month one	36 questions asking individuals questions about their general health and wellness, not disease-specific
Withings Heartrate & Activity	Continuously, for six months	Patient activity, sleep quality, and heart rate collected by the wearable watch

Secondary

Measure	Time frame	Description
Heart rate variability	Week two	Measurement of individual's change in pulse via a smartphone's onboard camera

Other

Measure	Time frame	Description
OASIS Baseline Questionnaire	Baseline, entered only upon enrollment	Basic Health Information and SLE-specific questions

Countries

United States

Contacts

Primary ContactEldon Jupe, Ph.D.

ejupe@progentec.com4052164818

Backup ContactRyan Newhardt, B.S.

rnewhardt@progentec.com4052130605

Outcome results