FLARE Lupus Research Study Systemic Lupus Erythematosus (FLARE)

December 9, 2019 updated by: Mymee Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 11215
        • Mymee Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: Mymee Program
A combination of digital therapeutics and telephonic health coaching is used to identify and test dietary, lifestyle, and environmental triggers in order to reduce symptoms of auto-immune disease.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory-Short Form (BPI-SF)
Time Frame: Change from baseline, measured at weeks 4, 8, 12, and 16 of the intervention and then every 3 months for the 1 year following the intervention
BPI-SF is a 9-item questionnaire with two domains: pain severity and pain interference. The pain severity items have values which range from 0 ("no pain") to 10 ("pain as bad as you can imagine"), and the pain interference items have values which range from 0 ("does not interfere") to 10 ("completely interferes"). The pain severity and pain interference domain scores can be calculated as the mean of the scores of their component items.
Change from baseline, measured at weeks 4, 8, 12, and 16 of the intervention and then every 3 months for the 1 year following the intervention
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Time Frame: Change from baseline, measured at weeks 4, 8, 12, and 16 of the intervention and then every 3 months for the 1 year following the intervention]
The FACIT-Fatigue Sale is a 13-item questionnaire assessing fatigue, where the items use a Likert-type scale (with values ranging from 0 to 4). The responses for each item are added to obtain a total score which ranges from 0 to 52, with a higher score indicating less fatigue.
Change from baseline, measured at weeks 4, 8, 12, and 16 of the intervention and then every 3 months for the 1 year following the intervention]
LupusQOL
Time Frame: Change from baseline, measured at weeks 4, 8, 12, and 16 of the intervention and then every 3 months for the 1 year following the intervention
LupusQoL is a Systemic Lupus Erythematosus (SLE) specific health-related quality of life measure. It is a 34-item questionnaire where each item uses a 5-point Likert-type scale (with values ranging from 0 to 4). Each item pertains to one of eight domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Each domain of the LupusQoL is scored separately. The score for each domain is equal to the average of the domain's items scaled such that the range of possible scores is 0 (worst health-related quality of life) to 100 (best health-related quality of life).
Change from baseline, measured at weeks 4, 8, 12, and 16 of the intervention and then every 3 months for the 1 year following the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in healthcare cost
Time Frame: 1 year
Comparison of healthcare costs over a one year period, pre- and post- intervention
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mymee Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2018

Primary Completion (Actual)

September 5, 2018

Study Completion (Actual)

December 5, 2019

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

February 7, 2018

First Posted (Actual)

February 8, 2018

Study Record Updates

Last Update Posted (Actual)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 9, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20172250

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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