Back to resultsFLARE Lupus Research Study Systemic Lupus Erythematosus (FLARE)
Primary Purpose
System; Lupus Erythematosus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mymee Program
Sponsored by
About this trial
This is an interventional treatment trial for System; Lupus Erythematosus focused on measuring SLE, FLARE, Lupus, Digital Therapeutics, Health Coaching, Smartphone App
Eligibility Criteria
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:
- 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
Sites / Locations
- Mymee Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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).
Secondary Outcome Measures
Change in healthcare cost
Comparison of healthcare costs over a one year period, pre- and post- intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03426384
Brief Title
FLARE Lupus Research Study Systemic Lupus Erythematosus
Acronym
FLARE
Official Title
Can Individualized Diet and Lifestyle Modifications Derived From Digital Therapeutics and Health Coaching Improve Symptoms of Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
September 5, 2018 (Actual)
Study Completion Date
December 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mymee Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
System; Lupus Erythematosus
Keywords
SLE, FLARE, Lupus, Digital Therapeutics, Health Coaching, Smartphone App
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mymee Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Pain Inventory-Short Form (BPI-SF)
Description
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.
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
Title
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Description
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.
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]
Title
LupusQOL
Description
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).
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
Secondary Outcome Measure Information:
Title
Change in healthcare cost
Description
Comparison of healthcare costs over a one year period, pre- and post- intervention
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
Facility Information:
Facility Name
Mymee Inc.
City
New York
State/Province
New York
ZIP/Postal Code
11215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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FLARE Lupus Research Study Systemic Lupus Erythematosus
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