Clinical trial NCT03426384: FLARE Lupus Research Study Systemic Lupus Erythematosus
Official title: Can Individualized Diet and Lifestyle Modifications Derived From Digital Therapeutics and Health Coaching Improve Symptoms of Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: System; Lupus Erythematosus
Keywords: SLE
FLARE
Lupus
Digital Therapeutics
Health Coaching
Smartphone App
Lead sponsor: Mymee Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Brief Pain Inventory-Short Form (BPI-SF)
timeFrame: 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
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
timeFrame: 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]
measure: LupusQOL
timeFrame: 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 outcomes:
measure: Change in healthcare cost
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Mymee Inc.
state: New York
Study officials:
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