Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data (GOOD-SHEPARD)
• 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.
Intravenous Immunoglobulin (IVIg) Therapy in a Home Infusion Setting
|Study Design:||Observational Model: Cohort|
|Official Title:||Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data (GOOD-SHEPARD)|
- Analysis of collected data captured in CareExchange™ will demonstrate the ability to show and track changes in outcome data. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Demonstration of response rate for those receiving IVIg. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
- Exhibit differences in response rate of IVIg therapy across disease states and demographics. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
- Demonstration of measured variables within patients who receive IVIg. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774331
|Contact: Timothy Walton, MHS, CCRPfirstname.lastname@example.org|
|Contact: Sarale Russ, RN, MSNemail@example.com|
|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|