Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data (GOOD-SHEPARD)

Study Overview
=================
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.

Official Title
-----------------
Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data (GOOD-SHEPARD)

Conditions
-----------------
Intravenous Immunoglobulin (IVIg) Therapy in a Home Infusion Setting

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immunoglobulin Therapy<br>Immunoglobulin Therapy | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of collected data captured in CareExchange™ will demonstrate the ability to show and track changes in outcome data. |  | 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |