FLARE Lupus Research Study Systemic Lupus Erythematosus



Status:Active, not recruiting
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/9/2019
Start Date:February 12, 2018
End Date:August 2019

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Can Individualized Diet and Lifestyle Modifications Derived From Digital Therapeutics and Health Coaching Improve Symptoms of 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
We found this trial at
1
site
New York, New York 11215
Principal Investigator: Faiz Khan, MD
Phone: 917-476-4122
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mi
from
New York, NY
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