FLARE Lupus Research Study Systemic Lupus Erythematosus

System; Lupus Erythematosus Clinical Trial

— FLARE  

Official title:

Can Individualized Diet and Lifestyle Modifications Derived From Digital Therapeutics and Health Coaching Improve Symptoms of Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426384
• Other study ID #: 20172250
• Status: Completed
• Phase: N/A
• Start date: February 12, 2018
• Est. completion date: December 5, 2019

Study information

• Verified date: December 2019
• Source: Mymee Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The first phase of this pilot study will assess changes in quality of life at the end of a 16-week Mymee program in patients with moderate to severe SLE. The second phase will assess changes in healthcare utilization and cost over a one year period after program end.

Description:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 5, 2019
• Est. primary completion date: September 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years of age who can consent for themselves

• 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:

• Pregnant and/or planning to get pregnant before end of 16-week intervention

• 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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• System; Lupus Erythematosus

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Mymee Inc.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Mymee Inc.

Country where clinical trial is conducted

United States, 

References & Publications (20)

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. Erratum in: PLoS One. 2017 Feb 6;12 (2):e0171877. PLoS One. 2019 Jul 24;14(7):e0220469. — View Citation

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, Alarcón G, Senécal 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. — View Citation

Davis LS, Reimold AM. Research and therapeutics-traditional and emerging therapies in systemic lupus erythematosus. Rheumatology (Oxford). 2017 Apr 1;56(suppl_1):i100-i113. doi: 10.1093/rheumatology/kew417. Review. — View Citation

Gulati G, Brunner HI. Environmental triggers in systemic lupus erythematosus. Semin Arthritis Rheum. 2018 Apr;47(5):710-717. doi: 10.1016/j.semarthrit.2017.10.001. Epub 2017 Oct 5. Review. — View Citation

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. — View Citation

Holloway L, Humphrey L, Heron L, Pilling C, Kitchen H, Højbjerre L, Strandberg-Larsen M, Hansen BB. Patient-reported outcome measures for systemic lupus erythematosus clinical trials: a review of content validity, face validity and psychometric performance. Health Qual Life Outcomes. 2014 Jul 22;12:116. doi: 10.1186/s12955-014-0116-1. Review. — View Citation

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. — View Citation

Kamen DL. Environmental influences on systemic lupus erythematosus expression. Rheum Dis Clin North Am. 2014 Aug;40(3):401-12, vii. doi: 10.1016/j.rdc.2014.05.003. Review. — View Citation

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. Review. — View Citation

Lightstone L, Doria A, Wilson H, Ward FL, Larosa M, Bargman JM. Can we manage lupus nephritis without chronic corticosteroids administration? Autoimmun Rev. 2018 Jan;17(1):4-10. doi: 10.1016/j.autrev.2017.11.002. Epub 2017 Nov 3. Review. — View Citation

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. — View Citation

Lisnevskaia L, Murphy G, Isenberg D. Systemic lupus erythematosus. Lancet. 2014 Nov 22;384(9957):1878-1888. doi: 10.1016/S0140-6736(14)60128-8. Epub 2014 May 31. Review. — View Citation

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. — View Citation

McKenzie AL, Hallberg SJ, Creighton BC, Volk BM, Link TM, Abner MK, Glon RM, McCarter JP, Volek JS, Phinney SD. A Novel Intervention Including Individualized Nutritional Recommendations Reduces Hemoglobin A1c Level, Medication Use, and Weight in Type 2 Diabetes. JMIR Diabetes. 2017 Mar 7;2(1):e5. doi: 10.2196/diabetes.6981. — View Citation

Mu Q, Zhang H, Luo XM. SLE: Another Autoimmune Disorder Influenced by Microbes and Diet? Front Immunol. 2015 Nov 30;6:608. doi: 10.3389/fimmu.2015.00608. eCollection 2015. Review. — View Citation

Pons-Estel GJ, Alarcón GS, Scofield L, Reinlib L, Cooper GS. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum. 2010 Feb;39(4):257-68. doi: 10.1016/j.semarthrit.2008.10.007. Epub 2009 Jan 10. Review. — View Citation

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. — View Citation

Somers EC, Marder W, Cagnoli P, Lewis EE, DeGuire P, Gordon C, Helmick CG, Wang L, Wing JJ, Dhar JP, Leisen J, Shaltis D, McCune WJ. Population-based incidence and prevalence of systemic lupus erythematosus: the Michigan Lupus Epidemiology and Surveillance program. Arthritis Rheumatol. 2014 Feb;66(2):369-78. doi: 10.1002/art.38238. — View Citation

Squance ML, Reeves GE, Bridgman H. The Lived Experience of Lupus Flares: Features, Triggers, and Management in an Australian Female Cohort. Int J Chronic Dis. 2014;2014:816729. doi: 10.1155/2014/816729. Epub 2014 Nov 20. — View Citation

Wild CP. Complementing the genome with an "exposome": the outstanding challenge of environmental exposure measurement in molecular epidemiology. Cancer Epidemiol Biomarkers Prev. 2005 Aug;14(8):1847-50. Review. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Pain Inventory-Short Form (BPI-SF)	BPI-SF is a 9-item questionnaire with two domains: pain severity and pain interference. The pain severity items have values which range from 0 ("no pain") to 10 ("pain as bad as you can imagine"), and the pain interference items have values which range from 0 ("does not interfere") to 10 ("completely interferes"). The pain severity and pain interference domain scores can be calculated as the mean of the scores of their component items.	Change from baseline, measured at weeks 4, 8, 12, and 16 of the intervention and then every 3 months for the 1 year following the intervention
Primary	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)	The FACIT-Fatigue Sale is a 13-item questionnaire assessing fatigue, where the items use a Likert-type scale (with values ranging from 0 to 4). The responses for each item are added to obtain a total score which ranges from 0 to 52, with a higher score indicating less fatigue.	Change from baseline, measured at weeks 4, 8, 12, and 16 of the intervention and then every 3 months for the 1 year following the intervention]
Primary	LupusQOL	LupusQoL is a Systemic Lupus Erythematosus (SLE) specific health-related quality of life measure. It is a 34-item questionnaire where each item uses a 5-point Likert-type scale (with values ranging from 0 to 4). Each item pertains to one of eight domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Each domain of the LupusQoL is scored separately. The score for each domain is equal to the average of the domain's items scaled such that the range of possible scores is 0 (worst health-related quality of life) to 100 (best health-related quality of life).	Change from baseline, measured at weeks 4, 8, 12, and 16 of the intervention and then every 3 months for the 1 year following the intervention
Secondary	Change in healthcare cost	Comparison of healthcare costs over a one year period, pre- and post- intervention	1 year