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FLARE Lupus Research Study Systemic Lupus Erythematosus | Clinical Trials | Clareo Health

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FLARE Lupus Research Study Systemic Lupus Erythematosus

Can Individualized Diet and Lifestyle Modifications Derived From Digital Therapeutics and Health Coaching Improve Symptoms of Systemic Lupus Erythematosus

NCT03426384•Mymee Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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.
+1 more criteria

Locations (1)

Mymee Inc.

New York, New York, United States

Key Dates

Start Date

February 12, 2018

Primary Completion Date

September 5, 2018

Completion Date

December 5, 2019

Last Updated

December 10, 2019

Enrollment

ACTUAL participants

Conditions

System; Lupus Erythematosus

Interventions

Mymee Program

BEHAVIORAL

Assessing the Impact of Herbal Supplement on Fatigue and Disease Activity in SLE: Results From an 8-Week Randomized Trial

NCT07398885

System; Lupus Erythematosus

View study

UNKNOWN

Translation of a Diagnostic Test for Lupus Flare Prediction From Bench to Clinic

NCT04018222

System; Lupus ErythematosusLupus Erythematosus+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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