Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data (GOOD-SHEPARD) (GOOD-SHEPARD)
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|ClinicalTrials.gov Identifier: NCT01774331|
Recruitment Status : Recruiting
First Posted : January 24, 2013
Last Update Posted : January 18, 2018
• 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.
- 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.
|Condition or disease|
|Intravenous Immunoglobulin (IVIg) Therapy in a Home Infusion Setting|
|Study Type :||Observational|
|Estimated Enrollment :||1500 participants|
|Official Title:||Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data (GOOD-SHEPARD)|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
- Analysis of collected data captured in CareExchange™ will demonstrate the ability to show and track changes in outcome data. [ Time Frame: 5 Years ]
- 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. [ Time Frame: 5 Years ]
- Demonstration of response rate for those receiving IVIg. [ Time Frame: 5 Years ]
- Exhibit differences in response rate of IVIg therapy across disease states and demographics. [ Time Frame: 5 Years ]
- Demonstration of measured variables within patients who receive IVIg. [ Time Frame: 5 Years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774331
|Contact: Timothy Walton, MHS, CCRPfirstname.lastname@example.org|
|United States, Kansas|
|AxelaCare Health Solutions, LLC||Recruiting|
|Lenexa, Kansas, United States, 66219|
|Principal Investigator:||Jeffrey A. Allen, MD||Northwestern University and University of Minnesota|