MedTrace Logo

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

NCT03142711 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2023-11-07

No results posted yet for this study

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.

Conditions

Interventions

OTHER

No Medical Intervention

Validation of phone ePRO

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Ampel BioSolutions, LLC

    collaborator INDUSTRY

  • Lupus Research Alliance

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2018-07-03
Completion
2018-07-03

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03142711 on ClinicalTrials.gov