FLARE Lupus Research Study Systemic Lupus Erythematosus

Description

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.

Study Start Date

February, 01 2018

Estimated Completion Date

August 2019

Interventions

  • Behavioral: Mymee Program

Study ID

Mymee Inc. -- 20172250

Status

Unknown

Trial ID

NCT03426384

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

40

Sponsor

Mymee Inc.

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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Mymee Inc - New York, New York 54.2 miles Mette Dyhrberg MS 917-476-4122 mette@mymee.com

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