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

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.

Study Overview

• Status: Terminated
• Conditions: Intravenous Immunoglobulin (IVIg) Therapy in a Home Infusion Setting

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.

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • AxelaCare Health Solutions, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Any patient who is aged 7 years or greater at time of enrollment; who is on Ig therapy, have been on or is between doses of Ig therapy, or is being considered to be prescribed Ig therapy; provides informed consent for participation; and who has been determined to be clinically eligible for infusion services by BriovaRx Infusion Servies (Formerly AxelaCare Health Solutions, LLC), in collaboration with the patient's prescribing physician. Subjects will be recruited from the practices of participating physicians.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Immunoglobulin Therapy

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: BriovaRx Infusion Services
• Investigators: Principal Investigator: Jeffrey A. Allen, MD, Northwestern University and University of Minnesota

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: January 18, 2013
• First Submitted That Met QC Criteria: January 22, 2013
• First Posted (Estimate): January 24, 2013

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: AHS1-12-001