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

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ClinicalTrials.gov Identifier: NCT03142711
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : January 16, 2018
Sponsor:
Collaborators:
Pfizer
Ampel BioSolutions, LLC
Information provided by (Responsible Party):
Lupus Research Alliance

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 Type : Observational
Estimated 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
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources


Intervention Details:
    Other: No Medical Intervention
    Validation of phone ePRO


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142711


Contacts
Contact: Claire Dykas 434-977-2675 claire.dykas@ampelbiosolutions.com

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30303
Contact: Sam Lim    404-616-5480    sslim@emory.edu   
United States, Massachusetts
Brigham and Women's HospitL Recruiting
Boston, Massachusetts, United States, 02115
Contact: Elena Massarotti    617-732-6523    emassarotti@partners.org   
United States, New York
Northwell Health Recruiting
Great Neck, New York, United States, 11021
Contact: Richard Furie    516-708-2550    rfurie@nshs.edu   
United States, Pennsylvania
Allegheny Health Network Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Susan Manzi    412-359-3022    smanzi@wpahs.org   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Narender Annapureddy    615-936-4073    narender.annapureddy@vanderbilt.edu   
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2S2
Contact: Stephanie Keeling    780-407-7540    stephanie.keeling@ualberta.ca   
Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3A 1M4
Contact: Christine Peschken    204-787-1851    christine.peschken@umanitoba.ca   
Canada, Ontario
McMaster University Medical Centre Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Mark Matsos    905-521-9034    matsosmp@mcmaster.ca   
University of Western Ontario/St. Joseph's Healthcare Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Janet Pope    519-646-6332    janet.pope@sjhc.london.on.ca   
Canada, Quebec
McGill University Health Centre Recruiting
Montréal, Quebec, Canada, H3G 1A4
Contact: Christian Pineau    514-934-1934    christian.pineau@mcgill.ca   
Sponsors and Collaborators
Lupus Research Alliance
Pfizer
Ampel BioSolutions, LLC

Responsible Party: Lupus Research Alliance
ClinicalTrials.gov Identifier: NCT03142711     History of Changes
Other Study ID Numbers: AMP-003
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
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