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

NCT03142711 | Completed

• 1 other identifier: AMP-003
• Study Type: observational
• Target: 80
• Locations: 2 countries
• Sites: 10

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

No Medical Intervention OTHER

Validation of phone ePRO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with SLE.

You may qualify if:

• Willing and able to provide written informed consent
• Males or females, aged 18 years or older
• Classification of SLE by either the American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics Classification (SLICC) criteria
• 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)
• Willing to perform and comply with all study procedures, including attending clinic visits at Baseline, Month 1, and Month 2 as scheduled

You may not qualify if:

• Rapidly progressive neurologic disease
• Cognitive dysfunction that might interfere with the capacity to use the ePRO device
• Any condition that might in the investigator's opinion might preclude completion of the study
• Current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 1 year prior to Screening
• 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.

Sponsors & Collaborators

• Lupus Research Alliance: lead
• Pfizer: collaborator
• Ampel BioSolutions, LLC: collaborator

Study Sites (10)

Emory University

Atlanta, Georgia, 30303, United States

Location

Brigham and Women's HospitL

Boston, Massachusetts, 02115, United States

Location

Northwell Health

Great Neck, New York, 11021, United States

Location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Alberta

Edmonton, Alberta, T6G 2S2, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3A 1M4, Canada

Location

McMaster University Medical Centre

Hamilton, Ontario, L8S 4K1, Canada

Location

University of Western Ontario/St. Joseph's Healthcare

London, Ontario, N6A 4V2, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Urine samples

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 5, 2017
• Study Start: August 21, 2017
• Primary Completion: July 3, 2018
• Study Completion: July 3, 2018
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); CA (5)