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

Systemic Lupus Erythematosus Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• SLE
• Systemic Lupus Erythematosus

• NCT number: NCT03142711
• Study type: Observational
• Source: Lupus Research Alliance
• Status: Completed
• Start date: August 21, 2017
• Completion date: July 3, 2018