Lupus Erythematosus, SystemicOASISNCT04449653
Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals
An observational study of Lupus Erythematosus, Systemic and Lupus Erythematosus, run by Progentec Diagnostics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lupus Erythematosus, Systemic, Lupus Erythematosus
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2020to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ryan Newhardt
Oklahoma City, Oklahoma, 73104
Ryan Newhardt, B.S., 405-213-0605, rnewhardt@progentec.com
Eldon Jupe, Ph.D.
About this study
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
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week two
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week three
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week four
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week five
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week six
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week seven
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week eight
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week nine
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week ten
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week eleven
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week twelve
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week thirteen
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week fourteen
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week fifteen
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week sixteen
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week seventeen
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week eighteen
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week nineteen
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week twenty
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week twenty-one
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week twenty-two
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week twenty-three
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week twenty-four
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week twenty-five
OASIS Wellness and Disease Questionnaire
Basic Health Information and Systemic Lupus Erythematosus-specific questions over the time span of a week
Measured: Week twenty-six
Short Form, 36 question form
36 questions asking individuals questions about their general health and wellness, not disease-specific
Measured: Month one
Short Form, 36 question form
36 questions asking individuals questions about their general health and wellness, not disease-specific
Measured: Month two
Short Form, 36 question form
36 questions asking individuals questions about their general health and wellness, not disease-specific
Measured: Month three
Short Form, 36 question form
36 questions asking individuals questions about their general health and wellness, not disease-specific
Measured: Month four
Short Form, 36 question form
36 questions asking individuals questions about their general health and wellness, not disease-specific
Measured: Month five
Short Form, 36 question form
36 questions asking individuals questions about their general health and wellness, not disease-specific
Measured: Month six
Withings Heartrate & Activity
Patient activity, sleep quality, and heart rate collected by the wearable watch
Measured: Continuously, for six months
Secondary outcomes (25)
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week two
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week three
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week four
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week five
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week six
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week seven
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week eight
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week nine
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week ten
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week eleven
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week twelve
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week thirteen
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week fourteen
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week fifteen
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week sixteen
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week seventeen
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week eighteen
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week nineteen
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week twenty
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week twenty-one
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week twenty-two
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week twenty-three
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week twenty-four
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week twenty-five
Heart rate variability
Measurement of individual's change in pulse via a smartphone's onboard camera
Measured: Week twenty-six
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start28 Apr 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Progentec Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eldon Jupe, Ph.D., Principal investigator, Progentec Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449653
- Sponsor's protocol ID
- MEASURE
- Acronym
- OASIS
- Status last verified
- Jun 2020
- First submitted
- 26 May 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals
- ClinicalTrials.gov ID
- NCT04449653
- Acronym / sponsor ID
- OASIS / MEASURE
- Conditions
- Lupus Erythematosus, Systemic, Lupus Erythematosus
- Keywords
- Lupus, SLE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Progentec Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Short Form, 36 question form
Time frame: Month one
36 questions asking individuals questions about their general health and wellness, not disease-specific
Short Form, 36 question form
Time frame: Month two
36 questions asking individuals questions about their general health and wellness, not disease-specific
Short Form, 36 question form
Time frame: Month three
36 questions asking individuals questions about their general health and wellness, not disease-specific
Short Form, 36 question form
Time frame: Month four
36 questions asking individuals questions about their general health and wellness, not disease-specific
Short Form, 36 question form
Time frame: Month five
36 questions asking individuals questions about their general health and wellness, not disease-specific
Short Form, 36 question form
Time frame: Month six
36 questions asking individuals questions about their general health and wellness, not disease-specific
Withings Heartrate & Activity
Time frame: Continuously, for six months
Patient activity, sleep quality, and heart rate collected by the wearable watch
25 secondary outcomes
Heart rate variability
Time frame: Week two
Heart rate variability
Time frame: Week three
Heart rate variability
Time frame: Week four
Heart rate variability
Time frame: Week five
Heart rate variability
Time frame: Week six
Heart rate variability
Time frame: Week seven
Heart rate variability
Time frame: Week eight
Heart rate variability
Time frame: Week nine
Heart rate variability
Time frame: Week ten
Heart rate variability
Time frame: Week eleven
Heart rate variability
Time frame: Week twelve
Heart rate variability
Time frame: Week thirteen
Heart rate variability
Time frame: Week fourteen
Heart rate variability
Time frame: Week fifteen
Heart rate variability
Time frame: Week sixteen
Heart rate variability
Time frame: Week seventeen
Heart rate variability
Time frame: Week eighteen
Heart rate variability
Time frame: Week nineteen
Heart rate variability
Time frame: Week twenty
Heart rate variability
Time frame: Week twenty-one
Heart rate variability
Time frame: Week twenty-two
Heart rate variability
Time frame: Week twenty-three
Heart rate variability
Time frame: Week twenty-four
Heart rate variability
Time frame: Week twenty-five
Heart rate variability
Time frame: Week twenty-six
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eldon Jupe, Ph.D. principal investigator
Progentec Diagnostics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, Systemic and Lupus Erythematosus, run by Progentec Diagnostics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eldon Jupe, Ph.D. (4052164818 ext. 3, ejupe@progentec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OASIS Wellness and Disease Questionnaire (time frame: Week two). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.