FLARE Lupus Research Study Systemic Lupus Erythematosus

Mymee

Status: Completed

Conditions: System; Lupus Erythematosus

Treatments: Behavioral: Mymee Program

Study type: Interventional

Funder types: Industry

Identifiers

NCT03426384

20172250

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Mymee Program

Control Group

No Intervention group

Description:

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.