FLARE Lupus Research Study Systemic Lupus Erythematosus
FLARE Lupus Research Study Systemic Lupus Erythematosus
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.
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.
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