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

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 Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus; Lupus Erythematosus, Systemic; SLE
• Intervention / Treatment: Other: No Medical Intervention

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2S2
      • University of Alberta
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M4
      • University of Manitoba
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster University Medical Centre
    • London, Ontario, Canada, N6A 4V2
      • University of Western Ontario/St. Joseph's Healthcare
  • Quebec
    • Montréal, Quebec, Canada, H3G 1A4
      • McGill University Health Centre
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's HospitL
  • New York
    • Great Neck, New York, United States, 11021
      • Northwell Health
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Health Network
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with SLE.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ePRO Validation	To evaluate measurement equivalence between the two PRO data collection modes - original paper mode versus the ePRO application on a handheld mobile phone for the following PRO's: SF-36 HRQoL questionnaire, the FACIT-F fatigue instrument, and the PtGA. The three PROs will be administered on clinic days by both modes: paper and ePRO. Concurrent results will be compared, and percentage similarities calculated.	7 months

Collaborators and Investigators

• Sponsor: Lupus Research Alliance
• Collaborators: Pfizer; Ampel BioSolutions, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2017
• Primary Completion (Actual): July 3, 2018
• Study Completion (Actual): July 3, 2018

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: AMP-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No