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 |
ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.