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

Systemic Lupus Erythematosus Clinical Trial

— VALUE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03142711
• Other study ID #: AMP-003
• Status: Completed
• Start date: August 21, 2017
• Est. completion date: July 3, 2018

Study information

• Verified date: November 2023
• Source: Lupus Research Alliance
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 3, 2018
• Est. primary completion date: July 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• SLE
• Systemic Lupus Erythematosus

Intervention

Other:
• No Medical Intervention
Validation of phone ePRO

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	University of Western Ontario/St. Joseph's Healthcare	London	Ontario
Canada	McGill University Health Centre	Montréal	Quebec
Canada	University of Manitoba	Winnipeg	Manitoba
United States	Emory University	Atlanta	Georgia
United States	Brigham and Women's HospitL	Boston	Massachusetts
United States	Northwell Health	Great Neck	New York
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Allegheny Health Network	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Lupus Research Alliance	Ampel BioSolutions, LLC, Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ePRO Validation	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.	7 months