AzTrials
AzTrials

System; Lupus ErythematosusFLARENCT03426384

FLARE Lupus Research Study Systemic Lupus Erythematosus

A study testing Mymee Program in people with System; Lupus Erythematosus, run by Mymee Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
System; Lupus Erythematosus
What is being tested?
Mymee Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
12 Feb 2018to 5 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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:
Show all 11Show fewer
  • a standing dose of oral steroid agents at a 20mg dose of prednisone (or other oral corticosteroid equivalent dose);
  • pulses or tapers of steroids for flares for more than a total of 30 days within the observation period
  • any pulse/taper dose of steroids during the last 4 weeks of the intervention period;
  • immunosuppressive agents, or biologic response modifiers.
  • Diagnosed with cancer

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mymee Inc.

    New York, New York, 11215

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Mymee Program
Keywords
SLE, FLARE, Lupus, Digital Therapeutics, Health Coaching, Smartphone App
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mymee ProgramBehavioural

    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.

Study groups in NCT03426384
Study groupRoleWhat they receive
Intervention GroupActive comparatorThe 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.
Receives: Behavioral: Mymee Program
Control GroupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Brief Pain Inventory-Short Form (BPI-SF)

    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.

    Measured: 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

  2. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

    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.

    Measured: 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]

  3. LupusQOL

    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).

    Measured: 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 outcomes (1)

  1. Change in healthcare cost

    Comparison of healthcare costs over a one year period, pre- and post- intervention

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2018
  2. Study start12 Feb 2018
  3. Primary completion5 Sep 2018
  4. Study completion5 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03426384
Sponsor's protocol ID
20172250
Acronym
FLARE
Status last verified
Dec 2019
First submitted
18 Jan 2018
Last updated
10 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kaul A, Gordon C, Crow MK, Touma Z, Urowitz MB, van Vollenhoven R, Ruiz-Irastorza G, Hughes G. Systemic lupus erythematosus. Nat Rev Dis Primers. 2016 Jun 16;2:16039. doi: 10.1038/nrdp.2016.39.

    PubMed 27306639

  • Lim SS, Bayakly AR, Helmick CG, Gordon C, Easley KA, Drenkard C. The incidence and prevalence of systemic lupus erythematosus, 2002-2004: The Georgia Lupus Registry. Arthritis Rheumatol. 2014 Feb;66(2):357-68. doi: 10.1002/art.38239.

    PubMed 24504808

  • Lisnevskaia L, Murphy G, Isenberg D. Systemic lupus erythematosus. Lancet. 2014 Nov 22;384(9957):1878-1888. doi: 10.1016/S0140-6736(14)60128-8. Epub 2014 May 31.

    PubMed 24881804

  • Somers EC, Marder W, Cagnoli P, Lewis EE, DeGuire P, Gordon C, Helmick CG, Wang L, Wing JJ, Dhar JP, Leisen J, Shaltis D, McCune WJ. Population-based incidence and prevalence of systemic lupus erythematosus: the Michigan Lupus Epidemiology and Surveillance program. Arthritis Rheumatol. 2014 Feb;66(2):369-78. doi: 10.1002/art.38238.

    PubMed 24504809

  • Davis LS, Reimold AM. Research and therapeutics-traditional and emerging therapies in systemic lupus erythematosus. Rheumatology (Oxford). 2017 Apr 1;56(suppl_1):i100-i113. doi: 10.1093/rheumatology/kew417.

    PubMed 28375452

  • Pons-Estel GJ, Alarcon GS, Scofield L, Reinlib L, Cooper GS. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum. 2010 Feb;39(4):257-68. doi: 10.1016/j.semarthrit.2008.10.007. Epub 2009 Jan 10.

    PubMed 19136143

  • Bernatsky S, Boivin JF, Joseph L, Manzi S, Ginzler E, Gladman DD, Urowitz M, Fortin PR, Petri M, Barr S, Gordon C, Bae SC, Isenberg D, Zoma A, Aranow C, Dooley MA, Nived O, Sturfelt G, Steinsson K, Alarcon G, Senecal JL, Zummer M, Hanly J, Ensworth S, Pope J, Edworthy S, Rahman A, Sibley J, El-Gabalawy H, McCarthy T, St Pierre Y, Clarke A, Ramsey-Goldman R. Mortality in systemic lupus erythematosus. Arthritis Rheum. 2006 Aug;54(8):2550-7. doi: 10.1002/art.21955.

    PubMed 16868977

  • Lightstone L, Doria A, Wilson H, Ward FL, Larosa M, Bargman JM. Can we manage lupus nephritis without chronic corticosteroids administration? Autoimmun Rev. 2018 Jan;17(1):4-10. doi: 10.1016/j.autrev.2017.11.002. Epub 2017 Nov 3.

    PubMed 29108828

  • Wild CP. Complementing the genome with an "exposome": the outstanding challenge of environmental exposure measurement in molecular epidemiology. Cancer Epidemiol Biomarkers Prev. 2005 Aug;14(8):1847-50. doi: 10.1158/1055-9965.EPI-05-0456. No abstract available.

    PubMed 16103423

  • Squance ML, Reeves GE, Bridgman H. The Lived Experience of Lupus Flares: Features, Triggers, and Management in an Australian Female Cohort. Int J Chronic Dis. 2014;2014:816729. doi: 10.1155/2014/816729. Epub 2014 Nov 20.

    PubMed 26464865

  • Kamen DL. Environmental influences on systemic lupus erythematosus expression. Rheum Dis Clin North Am. 2014 Aug;40(3):401-12, vii. doi: 10.1016/j.rdc.2014.05.003.

    PubMed 25034153

  • Gulati G, Brunner HI. Environmental triggers in systemic lupus erythematosus. Semin Arthritis Rheum. 2018 Apr;47(5):710-717. doi: 10.1016/j.semarthrit.2017.10.001. Epub 2017 Oct 5.

    PubMed 29169635

  • Mu Q, Zhang H, Luo XM. SLE: Another Autoimmune Disorder Influenced by Microbes and Diet? Front Immunol. 2015 Nov 30;6:608. doi: 10.3389/fimmu.2015.00608. eCollection 2015.

    PubMed 26648937

  • Bates MA, Brandenberger C, Langohr II, Kumagai K, Lock AL, Harkema JR, Holian A, Pestka JJ. Silica-Triggered Autoimmunity in Lupus-Prone Mice Blocked by Docosahexaenoic Acid Consumption. PLoS One. 2016 Aug 11;11(8):e0160622. doi: 10.1371/journal.pone.0160622. eCollection 2016.

    PubMed 27513935

  • He B, Hoang TK, Wang T, Ferris M, Taylor CM, Tian X, Luo M, Tran DQ, Zhou J, Tatevian N, Luo F, Molina JG, Blackburn MR, Gomez TH, Roos S, Rhoads JM, Liu Y. Resetting microbiota by Lactobacillus reuteri inhibits T reg deficiency-induced autoimmunity via adenosine A2A receptors. J Exp Med. 2017 Jan;214(1):107-123. doi: 10.1084/jem.20160961. Epub 2016 Dec 19.

    PubMed 27994068

Questions about this trial

What is this clinical trial studying?

A study testing Mymee Program in people with System; Lupus Erythematosus, run by Mymee Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03426384, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in