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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|