FLARE Lupus Research Study Systemic Lupus Erythematosus
NCT ID: NCT03426384
Last Updated: 2019-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2018-02-12
2019-12-05
Brief Summary
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Detailed Description
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Each subsequent week, the Health Coach will review and discuss with the subject the food diary and the data entered into the Mymee app during the previous week. Based on this discussion and the subject's medical records, the Health Coach will determine or revise which symptoms will continue to be monitored using the Mymee App.
Control Group The Control Group subjects will receive no training, coaching, or other intervention services from Mymee. The Control Group subjects will complete the same battery of assessments at the same intervals as the Intervention Group subjects.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Group
The Intervention Group will enter daily tasks into the Mymee app. After the first intake session, the subject will participate in weekly 20-30-minute coaching sessions with the Health Coach. At the second session, the Health Coach will review the symptoms and the free text entered by the subject to determine which dietary and environmental factors will be monitored in the Mymee app.
Each subsequent week, the Health Coach will review and discuss with the subject the food diary and the data entered into the Mymee app during the previous week. Based on this discussion and the subject's medical records, the Health Coach will determine or revise which symptoms will continue to be monitored using the Mymee App.
Mymee Program
A combination of digital therapeutics and telephonic health coaching is used to identify and test dietary, lifestyle, and environmental triggers in order to reduce symptoms of auto-immune disease.
Control Group
The Control Group subjects will receive no training, coaching, or other intervention services from Mymee. The Control Group subjects will complete the same battery of assessments at the same intervals as the Intervention Group subjects.
No interventions assigned to this group
Interventions
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Mymee Program
A combination of digital therapeutics and telephonic health coaching is used to identify and test dietary, lifestyle, and environmental triggers in order to reduce symptoms of auto-immune disease.
Eligibility Criteria
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Inclusion Criteria
* Location - U.S.
* Proficient in English (speaking, reading, and writing)
* Own or have reliable access to a smartphone (iPhone or Android)
* Provision of medical record
* Diagnosis of Lupus SLE as indicated in medical record
* Symptomatic lupus as indicated by a score of at least 6 on one or more of BPI-SF questions 3, 5, or 6 and/or a score of at least 3 on one or more of the first four questions on the FACIT
* Current prescription for one or more of the following medications: 20mg/day of oral prednisone (or other oral corticosteroid equivalent dose); methotrexate and/or other immunosuppressive therapy of any dosage such as cyclophosphamide (Cytoxan®), methotrexate (Rheumatrex™), or azathioprine (muran®), adalimumab (Humira Pen, Humira Pen Crohn's-UC-HS Start, Humira Pediatric Crohn's Start, Humira, and Humira Pen Psoriasis-Uveitis), Plaquenil, Cellcept; monoclonal antibodies (mAbs) such as Benlysta® (belimuab, formerly called LymphoStat-B™); rituximab (Rituxan, MabThera and others);
* Able and willing to consent to study protocol
* Medications which have been stable for 3 months
Exclusion Criteria
* In prison during any part of the 16-month study period
* Resident of a nursing home, wards of the state, or Institutionalized during any part of the 16-month study period
* Persons with decisional incapacity/cognitive impairment
* Participating in another clinical trial, interventional or observational research during the study period
* Plan or intention to receive/start during the 16-week (112 day) intervention period either:
1. a standing dose of oral steroid agents at a 20mg dose of prednisone (or other oral corticosteroid equivalent dose);
2. pulses or tapers of steroids for flares for more than a total of 30 days within the observation period
3. any pulse/taper dose of steroids during the last 4 weeks of the intervention period;
4. immunosuppressive agents, or biologic response modifiers.
* Diagnosed with cancer
18 Years
ALL
No
Sponsors
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Mymee Inc.
INDUSTRY
Responsible Party
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Locations
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Mymee Inc.
New York, New York, United States
Countries
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References
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Kaul A, Gordon C, Crow MK, Touma Z, Urowitz MB, van Vollenhoven R, Ruiz-Irastorza G, Hughes G. Systemic lupus erythematosus. Nat Rev Dis Primers. 2016 Jun 16;2:16039. doi: 10.1038/nrdp.2016.39.
Lim SS, Bayakly AR, Helmick CG, Gordon C, Easley KA, Drenkard C. The incidence and prevalence of systemic lupus erythematosus, 2002-2004: The Georgia Lupus Registry. Arthritis Rheumatol. 2014 Feb;66(2):357-68. doi: 10.1002/art.38239.
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Bernatsky S, Boivin JF, Joseph L, Manzi S, Ginzler E, Gladman DD, Urowitz M, Fortin PR, Petri M, Barr S, Gordon C, Bae SC, Isenberg D, Zoma A, Aranow C, Dooley MA, Nived O, Sturfelt G, Steinsson K, Alarcon G, Senecal JL, Zummer M, Hanly J, Ensworth S, Pope J, Edworthy S, Rahman A, Sibley J, El-Gabalawy H, McCarthy T, St Pierre Y, Clarke A, Ramsey-Goldman R. Mortality in systemic lupus erythematosus. Arthritis Rheum. 2006 Aug;54(8):2550-7. doi: 10.1002/art.21955.
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Bates MA, Brandenberger C, Langohr II, Kumagai K, Lock AL, Harkema JR, Holian A, Pestka JJ. Silica-Triggered Autoimmunity in Lupus-Prone Mice Blocked by Docosahexaenoic Acid Consumption. PLoS One. 2016 Aug 11;11(8):e0160622. doi: 10.1371/journal.pone.0160622. eCollection 2016.
He B, Hoang TK, Wang T, Ferris M, Taylor CM, Tian X, Luo M, Tran DQ, Zhou J, Tatevian N, Luo F, Molina JG, Blackburn MR, Gomez TH, Roos S, Rhoads JM, Liu Y. Resetting microbiota by Lactobacillus reuteri inhibits T reg deficiency-induced autoimmunity via adenosine A2A receptors. J Exp Med. 2017 Jan;214(1):107-123. doi: 10.1084/jem.20160961. Epub 2016 Dec 19.
Sepah SC, Jiang L, Peters AL. Long-term outcomes of a Web-based diabetes prevention program: 2-year results of a single-arm longitudinal study. J Med Internet Res. 2015 Apr 10;17(4):e92. doi: 10.2196/jmir.4052.
Hsu WC, Lau KH, Huang R, Ghiloni S, Le H, Gilroy S, Abrahamson M, Moore J. Utilization of a Cloud-Based Diabetes Management Program for Insulin Initiation and Titration Enables Collaborative Decision Making Between Healthcare Providers and Patients. Diabetes Technol Ther. 2016 Feb;18(2):59-67. doi: 10.1089/dia.2015.0160. Epub 2015 Dec 8.
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McElhone K, Abbott J, Sutton C, Mullen M, Lanyon P, Rahman A, Yee CS, Akil M, Bruce IN, Ahmad Y, Gordon C, Teh LS. Sensitivity to Change and Minimal Important Differences of the LupusQoL in Patients With Systemic Lupus Erythematosus. Arthritis Care Res (Hoboken). 2016 Oct;68(10):1505-13. doi: 10.1002/acr.22850. Epub 2016 Sep 2.
Khan F, Granville N, Malkani R, Chathampally Y. Health-Related Quality of Life Improvements in Systemic Lupus Erythematosus Derived from a Digital Therapeutic Plus Tele-Health Coaching Intervention: Randomized Controlled Pilot Trial. J Med Internet Res. 2020 Oct 20;22(10):e23868. doi: 10.2196/23868.
Other Identifiers
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20172250
Identifier Type: -
Identifier Source: org_study_id