The purpose of this study is to demonstrate the utility of measuring outcomes in 5% treatment naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) patients using infusion nurse and patient measured physical, quality of life (QOL), respiratory, and disability assessments using CareExchange in the home setting.
Study Type
OBSERVATIONAL
Enrollment
20
Hoag Medical Group (In Alliance with St. Joseph Heritage Healthcare)
Newport Beach, California, United States
IMMUNEOe International Research Centers
Centennial, Colorado, United States
Atlanta ENT
Atlanta, Georgia, United States
AxelaCare Health Solutions, LLC
Lenexa, Kansas, United States
Analysis of collected data captured in CareExchange will demonstrate the ability to show and track changes in outcome data in 5% treatment naïve IVIg PIDD patients in the home setting.
Time frame: 1 year
Evaluate the profile physician usage (dose and timing) with Gammaplex®.
Time frame: 1 year
Evaluate physician feedback to having real-time access to 5% treatment naïve IVIg PIDD data captured during home infusions.
Time frame: 1 year
Evaluate the safety profile of using a 5% treatment naïve IVIg in PIDD patients in the home setting.
Time frame: 1 year
Demonstration of response rate for those receiving IVIg therapies.
Time frame: 1 year
Demonstration of changes in outcomes as a result of changes made in IVIg dose and frequency during study participation.
Time frame: 1 year
Demonstration of measured variables within patients who receive IVIg therapies.
Time frame: 1 year
Evaluate the effectiveness of whether CareExchange leads to better QOLs and overall patient reported outcomes.
Time frame: 1 year
Other potential impacts on change in outcomes across patient demographics (age, sex, race, ethnicity, etc.).
Time frame: 1 year
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