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Trial record 1 of 8 for:    lupus research alliance
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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 : Completed
First Posted : May 5, 2017
Last Update Posted : December 3, 2018
Ampel BioSolutions, LLC
Information provided by (Responsible Party):
Lupus Research Alliance

Tracking Information
First Submitted Date May 3, 2017
First Posted Date May 5, 2017
Last Update Posted Date December 3, 2018
Actual Study Start Date August 21, 2017
Actual Primary Completion Date July 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 4, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Validation of a Mobile Phone Based on EPRO Tool in Subjects With Systemic Lupus Erythematosus
Official Title Validation of a Mobile Phone Based on EPRO Tool in Subjects With Systemic Lupus Erythematosus
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Blood and Urine samples
Sampling Method Non-Probability Sample
Study Population Patients with SLE.
  • SLE
  • Lupus Erythematosus, Systemic
  • Systemic Lupus Erythematosus
Intervention Other: No Medical Intervention
Validation of phone ePRO
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 4, 2017)
Original Estimated Enrollment Same as current
Actual Study Completion Date July 3, 2018
Actual Primary Completion Date July 3, 2018   (Final data collection date for primary outcome measure)
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.
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
Administrative Information
NCT Number NCT03142711
Other Study ID Numbers AMP-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Lupus Research Alliance
Original Responsible Party Same as current
Current Study Sponsor Lupus Research Alliance
Original Study Sponsor Same as current
  • Pfizer
  • Ampel BioSolutions, LLC
Investigators Not Provided
PRS Account Lupus Research Alliance
Verification Date November 2018