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

NCT ID: NCT03142711

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-21
• Study Completion Date: 2018-07-03

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.

Conditions

SLE; Lupus Erythematosus, Systemic; Systemic Lupus Erythematosus

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

No Medical Intervention

Validation of phone ePRO

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Ampel BioSolutions, LLC

INDUSTRY

Sponsor Role: collaborator

Lupus Research Alliance

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; Canada

Other Identifiers

AMP-003

Identifier Type: -

Identifier Source: org_study_id