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

• ClinicalTrials.gov Identifier: NCT03142711
• Recruitment Status: Completed
• First Posted: May 5, 2017
• Last Update Posted: November 7, 2023
• Sponsor: Lupus Research Alliance
• Collaborators: Pfizer; Ampel BioSolutions, LLC
• Information provided by (Responsible Party): Lupus Research Alliance

Study Description

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.

Condition or disease	Intervention/treatment
SLE; Lupus Erythematosus, Systemic; Systemic Lupus Erythematosus	Other: No Medical Intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Validation of a Mobile Phone Based on EPRO Tool in Subjects With Systemic Lupus Erythematosus
• Actual Study Start Date: August 21, 2017
• Actual Primary Completion Date: July 3, 2018
• Actual Study Completion Date: July 3, 2018

Groups and Cohorts

Intervention Details:

• Other: No Medical Intervention
  Validation of phone ePRO

Outcome Measures

Primary Outcome Measures :

1. ePRO Validation [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA

Blood and Urine samples

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with SLE.

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.

Contacts and Locations

Locations

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30303

United States, Massachusetts

Brigham and Women's HospitL

Boston, Massachusetts, United States, 02115

United States, New York

Northwell Health

Great Neck, New York, United States, 11021

United States, Pennsylvania

Allegheny Health Network

Pittsburgh, Pennsylvania, United States, 15212

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Canada, Alberta

University of Alberta

Edmonton, Alberta, Canada, T6G 2S2

Canada, Manitoba

University of Manitoba

Winnipeg, Manitoba, Canada, R3A 1M4

Canada, Ontario

McMaster University Medical Centre

Hamilton, Ontario, Canada, L8S 4K1

University of Western Ontario/St. Joseph's Healthcare

London, Ontario, Canada, N6A 4V2

Canada, Quebec

McGill University Health Centre

Montréal, Quebec, Canada, H3G 1A4

Sponsors and Collaborators

Lupus Research Alliance

Pfizer

Ampel BioSolutions, LLC

More Information

• Responsible Party: Lupus Research Alliance
• ClinicalTrials.gov Identifier: NCT03142711
• Other Study ID Numbers: AMP-003
• First Posted: May 5, 2017
• Last Update Posted: November 7, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases