Validation of a Mobile Phone Based on EPRO Tool in Subjects With Systemic Lupus Erythematosus

Description

Systemic lupus erythematosus (SLE) may involve a variety of organ systems expressed differently from patient to patient, and so can be difficult to characterize clinically. Patient reported outcomes (PROs), which consist of feedback directly from patients regarding their symptoms without interpretation by a clinician, are typically used in SLE to supplement other clinical measures. Standard PROs typically used in SLE include the 36-item short form health survey (SF-36), the functional assessment of chronic illness therapy - fatigue (FACIT-F), and the patient global assessment (PtGA), administered by paper or electronic tablet during the clinic visits. The recent development of electronic mobile device technology, such as the smartphone, has made it possible to collect PRO information away from the clinical site in the subject's environment. This study will assess by measurement equivalence testing whether data collected via a smartphone are comparable to that collected in standard fashion and whether PROs obtained in the subject's environment may be more informative than that collected in the physician's office on paper.

Study Start Date

August, 21 2017

Estimated Completion Date

May 2018

Interventions

  • Other: No Medical Intervention

Study ID

Lupus Research Alliance -- AMP-003

Status

Recruiting

Trial ID

NCT03142711

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

80

Sponsor

Lupus Research Alliance

Inclusion Criteria

    1. Willing and able to provide written informed consent 2. Males or females, aged 18 years or older 3. Classification of SLE by either the American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics Classification (SLICC) criteria 4. On a stable SLE treatment regimen consisting of any of the following medications for a period of at least 30 days prior to Screening
  • Corticosteroids (<30 mg prednisone or equivalent per day)
  • Hydroxychloroquine or equivalent anti-malarial
  • Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil or sodium), cyclophosphasmide, belimumab, calcineurin inhibitors (e.g. tacrolimus, cyclosporine) 5. Willing to perform and comply with all study procedures, including attending clinic visits at Baseline, Month 1, and Month 2 as scheduled

Exclusion Criteria

    1. Rapidly progressive neurologic disease 2. Cognitive dysfunction that might interfere with the capacity to use the ePRO device 3. Any condition that might in the investigator's opinion might preclude completion of the study 4. Current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 1 year prior to Screening 5. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not caused by SLE (e.g., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the Investigator, could confound the results of the study or put the subject at undue risk.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (9)

Study Location Distance Name Phone Email
Brigham and Womens HospitL - Boston, Massachusetts 2.6 miles Elena Massarotti 617-732-6523 emassarotti@partners.org
Brigham and Womens HospitL - Boston, Massachusetts 2.6 miles Elena Massarotti 617-732-6523 emassarotti@partners.org
Brigham and Womens HospitL - Boston, Massachusetts 2.6 miles Elena Massarotti 617-732-6523 emassarotti@partners.org
Brigham and Womens HospitL - Boston, Massachusetts 2.6 miles Elena Massarotti 617-732-6523 emassarotti@partners.org
Brigham and Womens HospitL - Boston, Massachusetts 2.6 miles Elena Massarotti 617-732-6523 emassarotti@partners.org
Northwell Health - Great Neck, New York 174.4 miles Richard Furie 516-708-2550 rfurie@nshs.edu
Allegheny Health Network - Pittsburgh, Pennsylvania 480.9 miles Susan Manzi 412-359-3022 smanzi@wpahs.org
Emory University - Atlanta, Georgia 936.6 miles Sam Lim 404-616-5480 sslim@emory.edu
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles Narender Annapureddy 615-936-4073 narender.annapureddy@vanderbilt.edu

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