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
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 | |
---|---|---|---|---|
Mymee Inc - New York, New York | 54.2 miles | Mette Dyhrberg MS | 917-476-4122 | mette@mymee.com |