Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data (GOOD-SHEPARD)
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 7 - Any |
| Updated: | 1/31/2019 |
| Start Date: | November 2012 |
| End Date: | November 2020 |
| Contact: | Timothy Walton, MHS, CCRP |
| Email: | twalton@axelacare.com |
| Phone: | 877-342-9352 |
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.
• 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.
This is a prospective, observational evaluation of immunoglobulin (Ig) therapy in consenting
adult and assenting pediatric subjects who receive infusion services from 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.
adult and assenting pediatric subjects who receive infusion services from 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.
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 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
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