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

• Sponsor: Lupus Research Alliance (Other)
• Overall Status: Completed
• CT.gov ID: NCT03142711
• Collaborator: Pfizer (Industry), Ampel BioSolutions, LLC (Industry)
• Enrollment: 80
• Locations: 10
• Actual Duration (Months): 10.4
• Patients Per Site: 8
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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	Phase
SLE; Lupus Erythematosus, Systemic; Systemic Lupus Erythematosus	Other: No Medical Intervention

Study Design

• Study Type: Observational
• Actual 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: Aug 21, 2017
• Actual Primary Completion Date: Jul 3, 2018
• Actual Study Completion Date: Jul 3, 2018

Outcome Measures

Primary Outcome Measures

1. ePRO Validation [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30303
2	Brigham and Women's HospitL	Boston	Massachusetts	United States	02115
3	Northwell Health	Great Neck	New York	United States	11021
4	Allegheny Health Network	Pittsburgh	Pennsylvania	United States	15212
5	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
6	University of Alberta	Edmonton	Alberta	Canada	T6G 2S2
7	University of Manitoba	Winnipeg	Manitoba	Canada	R3A 1M4
8	McMaster University Medical Centre	Hamilton	Ontario	Canada	L8S 4K1
9	University of Western Ontario/St. Joseph's Healthcare	London	Ontario	Canada	N6A 4V2
10	McGill University Health Centre	Montréal	Quebec	Canada	H3G 1A4

Sponsors and Collaborators

• Lupus Research Alliance
• Pfizer
• Ampel BioSolutions, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lupus Research Alliance
• ClinicalTrials.gov Identifier: NCT03142711
• Other Study ID Numbers: AMP-003
• First Posted: May 5, 2017
• Last Update Posted: Dec 3, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of Dec 3, 2018