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

NCT03142711

Last updated date
Study Location
Emory University
Atlanta, Georgia, 30303, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
SLE, Systemic Lupus Erythematosus, Systemic Lupus Erythematosus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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SLE, Systemic Lupus Erythematosus, Systemic Lupus ErythematosusValidation of a Mobile Phone Based on EPRO Tool in Subjects With Systemic Lupus Erythematosus
NCT03142711
  1. Atlanta, Georgia
  2. Boston, Massachusetts
  3. Great Neck, New York
  4. Pittsburgh, Pennsylvania
  5. Nashville, Tennessee
  6. Edmonton, Alberta
  7. Winnipeg, Manitoba
  8. Hamilton, Ontario
  9. London, Ontario
  10. Montréal, Quebec
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
Description:
Blood and Urine samples
Sampling Method Non-Probability Sample
Study Population Patients with SLE.
Condition
  • 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)
80
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.
Sex/Gender
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
Responsible Party Lupus Research Alliance
Study Sponsor Lupus Research Alliance
Collaborators
  • Pfizer
  • Ampel BioSolutions, LLC
Investigators Not Provided
PRS Account Lupus Research Alliance
Verification Date November 2018