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

NCT01774331 | Terminated

• 1 other identifier: AHS1-12-001
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Intravenous Immunoglobulin (IVIg) Therapy in a Home Infusion Setting

Outcome Measures

Primary Outcomes (1)

• Analysis of collected data captured in CareExchange™ will demonstrate the ability to show and track changes in outcome data.

  5 Years

Secondary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Immunoglobulin Therapy

Immunoglobulin Therapy

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Children (age ≤ 6 years)
• Prisoners, and other wards of the state

Sponsors & Collaborators

• BriovaRx Infusion Services: lead

Study Sites (1)

AxelaCare Health Solutions, LLC

Lenexa, Kansas, 66219, United States

Location

Study Officials

• Jeffrey A. Allen, MD

  Northwestern University and University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2013
• First Posted: January 24, 2013
• Study Start: November 1, 2012
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

US (1)