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

Completed

• Conditions: Lupus Erythematosus, Systemic; SLE; Systemic Lupus Erythematosus

• Registration Number: NCT03142711
• Lead Sponsor: Lupus Research Alliance

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-05
• Study Start: 2017-08-21
• Primary Completion: 2018-07-03
• Study Completion: 2018-07-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ePRO Validation	7 months	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.

Trial Locations

Locations (10)

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

Brigham and Women's HospitL; 🇺🇸 Boston, Massachusetts, United States

Northwell Health; 🇺🇸 Great Neck, New York, United States

Allegheny Health Network; 🇺🇸 Pittsburgh, Pennsylvania, United States

McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada

University of Western Ontario/St. Joseph's Healthcare; 🇨🇦 London, Ontario, Canada

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada