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

Tracking Information

• First Submitted Date: May 3, 2017
• First Posted Date: May 5, 2017
• Last Update Posted Date: November 7, 2023
• 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
• 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

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

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

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

Collaborators

• Pfizer
• Ampel BioSolutions, LLC

• Investigators: Not Provided
• PRS Account: Lupus Research Alliance
• Verification Date: November 2023