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

NCT04449653 | Unknown

• 1 other identifier: MEASURE
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Lupus Erythematosus, Systemic; Lupus Erythematosus

Keywords

Lupus; SLE

Outcome Measures

Primary Outcomes (32)

• 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 Outcomes (25)

• Heart rate variability

  Week two

• Heart rate variability

  Week three

• Heart rate variability

  Week four

• Heart rate variability

  Week five

• Heart rate variability

  Week six

Other Outcomes (1)

• OASIS Baseline Questionnaire

  Baseline, entered only upon enrollment

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Progentec Diagnostics, Inc.: lead

Study Sites (1)

Ryan Newhardt

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eldon Jupe, Ph.D.

  Progentec Diagnostics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eldon Jupe, Ph.D.

CONTACT

4052164818; ejupe@progentec.com

Ryan Newhardt, B.S.

CONTACT

4052130605; rnewhardt@progentec.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 29, 2020
• Study Start: April 28, 2020
• Primary Completion: December 31, 2020
• Study Completion: June 1, 2021
• Last Updated: June 29, 2020

Record last verified: 2020-06

Locations

US (1)