Intravenous Immunoglobulin (IVIg) Therapy in a Home Infusion Setting
Conditions
Brief summary
Primary: • Demonstrate the utility of a new electronic data capture (EDC) system (CareExchange™) using infusion nurse measured physical, quality of life (QOL), respiratory, and disability assessments. Secondary: * Change in Intravenous Immunoglobulin (IVIg) dose effects measured outcomes. * Change in IVIg dose and timing effects measured outcomes. * Change in patient status is reflected in measured outcomes. * Assess the value to physicians from infusion nurse collected outcomes data. * Identify types of patients by response to IVIg therapy (i.e. natural or poor responders). * Change in response rate to IVIg therapy by disease state and demographics.
Detailed description
This is a prospective, observational evaluation of immunoglobulin (Ig) therapy in consenting adult and assenting pediatric subjects who receive infusion services from BriovaRx Infusion Services, (Formerly AxelaCare Health Solutions, LLC). Subjects meeting all inclusion criteria who have provided informed consent/assent for trial participation will have validated, physician-prescribed, and standard-of-care outcome measures recorded during normal home infusion visits. Collected data will be de-identified and aggregated into cohorts of like diagnosis for trend analysis.
Interventions
None listed
Sponsors
BriovaRx Infusion Services
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age at enrollment ≥ 7 * Sign informed consent/assented to participation * Ability to read and write English * Understanding of study procedures and ability to comply with study procedures for the entire length of the study * Receiving IVIg under the discretion of the patient's treating physician in accordance with standard treatment practices * Have been on or is between doses of IVIg under the discretion of the patient's treating physician in accordance with standard treatment practices * Being considered to be prescribed IVIg under the discretion of the patient's treating physician in accordance with standard treatment practices * Determined to be clinically eligible for infusion services by BriovaRx Infusion Services (Formerly AxelaCare Health Solutions, LLC.) in collaboration with the patient's prescribing physician
Exclusion criteria
* Children (age ≤ 6 years) * Prisoners, and other wards of the state
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of collected data captured in CareExchange™ will demonstrate the ability to show and track changes in outcome data. | 5 Years |
Secondary
| Measure | Time frame |
|---|---|
| Physician feedback will demonstrate that having real-time access to patient data captured during a home infusion will assist in the management of the patient's disease. | 5 Years |
Other
| Measure | Time frame |
|---|---|
| Demonstration of response rate for those receiving IVIg. | 5 Years |
| Exhibit differences in response rate of IVIg therapy across disease states and demographics. | 5 Years |
| Demonstration of measured variables within patients who receive IVIg. | 5 Years |
Countries
United States
Outcome results
None listed