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

June 23, 2020 updated by: Progentec Diagnostics, Inc.
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Ryan Newhardt
        • Contact:
        • Principal Investigator:
          • Eldon Jupe, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
OASIS Wellness and Disease Questionnaire
Time Frame: Week two
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week two
OASIS Wellness and Disease Questionnaire
Time Frame: Week three
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week three
OASIS Wellness and Disease Questionnaire
Time Frame: Week four
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week four
OASIS Wellness and Disease Questionnaire
Time Frame: Week five
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week five
OASIS Wellness and Disease Questionnaire
Time Frame: Week six
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week six
OASIS Wellness and Disease Questionnaire
Time Frame: Week seven
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week seven
OASIS Wellness and Disease Questionnaire
Time Frame: Week eight
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week eight
OASIS Wellness and Disease Questionnaire
Time Frame: Week nine
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week nine
OASIS Wellness and Disease Questionnaire
Time Frame: Week ten
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week ten
OASIS Wellness and Disease Questionnaire
Time Frame: Week eleven
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week eleven
OASIS Wellness and Disease Questionnaire
Time Frame: Week twelve
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week twelve
OASIS Wellness and Disease Questionnaire
Time Frame: Week thirteen
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week thirteen
OASIS Wellness and Disease Questionnaire
Time Frame: Week fourteen
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week fourteen
OASIS Wellness and Disease Questionnaire
Time Frame: Week fifteen
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week fifteen
OASIS Wellness and Disease Questionnaire
Time Frame: Week sixteen
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week sixteen
OASIS Wellness and Disease Questionnaire
Time Frame: Week seventeen
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week seventeen
OASIS Wellness and Disease Questionnaire
Time Frame: Week eighteen
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week eighteen
OASIS Wellness and Disease Questionnaire
Time Frame: Week nineteen
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week nineteen
OASIS Wellness and Disease Questionnaire
Time Frame: Week twenty
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week twenty
OASIS Wellness and Disease Questionnaire
Time Frame: Week twenty-one
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week twenty-one
OASIS Wellness and Disease Questionnaire
Time Frame: Week twenty-two
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week twenty-two
OASIS Wellness and Disease Questionnaire
Time Frame: Week twenty-three
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week twenty-three
OASIS Wellness and Disease Questionnaire
Time Frame: Week twenty-four
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week twenty-four
OASIS Wellness and Disease Questionnaire
Time Frame: Week twenty-five
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week twenty-five
OASIS Wellness and Disease Questionnaire
Time Frame: Week twenty-six
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Week twenty-six
Short Form, 36 question form
Time Frame: Month one
36 questions asking individuals questions about their general health and wellness, not disease-specific
Month one
Short Form, 36 question form
Time Frame: Month two
36 questions asking individuals questions about their general health and wellness, not disease-specific
Month two
Short Form, 36 question form
Time Frame: Month three
36 questions asking individuals questions about their general health and wellness, not disease-specific
Month three
Short Form, 36 question form
Time Frame: Month four
36 questions asking individuals questions about their general health and wellness, not disease-specific
Month four
Short Form, 36 question form
Time Frame: Month five
36 questions asking individuals questions about their general health and wellness, not disease-specific
Month five
Short Form, 36 question form
Time Frame: Month six
36 questions asking individuals questions about their general health and wellness, not disease-specific
Month six
Withings Heartrate & Activity
Time Frame: Continuously, for six months
Patient activity, sleep quality, and heart rate collected by the wearable watch
Continuously, for six months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: Week two
Measurement of individual's change in pulse via a smartphone's onboard camera
Week two
Heart rate variability
Time Frame: Week three
Measurement of individual's change in pulse via a smartphone's onboard camera
Week three
Heart rate variability
Time Frame: Week four
Measurement of individual's change in pulse via a smartphone's onboard camera
Week four
Heart rate variability
Time Frame: Week five
Measurement of individual's change in pulse via a smartphone's onboard camera
Week five
Heart rate variability
Time Frame: Week six
Measurement of individual's change in pulse via a smartphone's onboard camera
Week six
Heart rate variability
Time Frame: Week seven
Measurement of individual's change in pulse via a smartphone's onboard camera
Week seven
Heart rate variability
Time Frame: Week eight
Measurement of individual's change in pulse via a smartphone's onboard camera
Week eight
Heart rate variability
Time Frame: Week nine
Measurement of individual's change in pulse via a smartphone's onboard camera
Week nine
Heart rate variability
Time Frame: Week ten
Measurement of individual's change in pulse via a smartphone's onboard camera
Week ten
Heart rate variability
Time Frame: Week eleven
Measurement of individual's change in pulse via a smartphone's onboard camera
Week eleven
Heart rate variability
Time Frame: Week twelve
Measurement of individual's change in pulse via a smartphone's onboard camera
Week twelve
Heart rate variability
Time Frame: Week thirteen
Measurement of individual's change in pulse via a smartphone's onboard camera
Week thirteen
Heart rate variability
Time Frame: Week fourteen
Measurement of individual's change in pulse via a smartphone's onboard camera
Week fourteen
Heart rate variability
Time Frame: Week fifteen
Measurement of individual's change in pulse via a smartphone's onboard camera
Week fifteen
Heart rate variability
Time Frame: Week sixteen
Measurement of individual's change in pulse via a smartphone's onboard camera
Week sixteen
Heart rate variability
Time Frame: Week seventeen
Measurement of individual's change in pulse via a smartphone's onboard camera
Week seventeen
Heart rate variability
Time Frame: Week eighteen
Measurement of individual's change in pulse via a smartphone's onboard camera
Week eighteen
Heart rate variability
Time Frame: Week nineteen
Measurement of individual's change in pulse via a smartphone's onboard camera
Week nineteen
Heart rate variability
Time Frame: Week twenty
Measurement of individual's change in pulse via a smartphone's onboard camera
Week twenty
Heart rate variability
Time Frame: Week twenty-one
Measurement of individual's change in pulse via a smartphone's onboard camera
Week twenty-one
Heart rate variability
Time Frame: Week twenty-two
Measurement of individual's change in pulse via a smartphone's onboard camera
Week twenty-two
Heart rate variability
Time Frame: Week twenty-three
Measurement of individual's change in pulse via a smartphone's onboard camera
Week twenty-three
Heart rate variability
Time Frame: Week twenty-four
Measurement of individual's change in pulse via a smartphone's onboard camera
Week twenty-four
Heart rate variability
Time Frame: Week twenty-five
Measurement of individual's change in pulse via a smartphone's onboard camera
Week twenty-five
Heart rate variability
Time Frame: Week twenty-six
Measurement of individual's change in pulse via a smartphone's onboard camera
Week twenty-six

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
OASIS Baseline Questionnaire
Time Frame: Baseline, entered only upon enrollment
Basic Health Information and SLE-specific questions
Baseline, entered only upon enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Progentec Diagnostics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eldon Jupe, Ph.D., Progentec Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MEASURE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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