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

Completed

Conditions studied: SLE, Lupus Erythematosus, Systemic, Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID: NCT03142711
Run by: Lupus Research Alliance
People needed: 80
Starts: 2017-08-21
Expected to finish: 2018-07-03
Last updated by the study team: 2023-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Willing and able to provide written informed consent
Males or females, aged 18 years or older
Classification of SLE by either the American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics Classification (SLICC) criteria
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)
Willing to perform and comply with all study procedures, including attending clinic visits at Baseline, Month 1, and Month 2 as scheduled

You may not qualify if…

Rapidly progressive neurologic disease
Cognitive dysfunction that might interfere with the capacity to use the ePRO device
Any condition that might in the investigator's opinion might preclude completion of the study
Current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 1 year prior to Screening
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.

Where it is running

Emory University — Atlanta, Georgia, United States
Brigham and Women's HospitL — Boston, Massachusetts, United States
Northwell Health — Great Neck, New York, United States
Allegheny Health Network — Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States
University of Alberta — Edmonton, Alberta, Canada
University of Manitoba — Winnipeg, Manitoba, Canada
McMaster University Medical Centre — Hamilton, Ontario, Canada
University of Western Ontario/St. Joseph's Healthcare — London, Ontario, Canada
McGill University Health Centre — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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