Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)
- Demonstrate the utility of an electronic data capture (EDC) system (CareExchange™) using infusion nurse and patient measured physical, quality of life (QOL), respiratory, laboratory, and disability assessments in patients with Primary Immunodeficiency Disease (PIDD).
- Change in Intravenous/Subcutaneous Immunoglobulin (IVIg/SCIg) dose effects measured outcomes.
- Change in IVIg/SCIg dose timing effects measured outcomes.
- Change in patient status is reflected in measured outcomes.
- Assess the value to physicians from collected outcomes data.
- Identify types of patients by response to IVIg/SCIg therapies (well maintained, problematic, etc.).
- Change in response rate as measured by outcomes to IVIg/SCIg therapies by disease state, co-morbidities, and demographics.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data in Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)|
- Analysis of collected data captured in CareExchange™ -ability to show and track changes in outcome data in PIDD patients. [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
- Physician feedback will demonstrate if having real-time access to patient data captured during a home infusion will assist in the management of the patient's disease. [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
- Response rate for those receiving IVIg/SCIg therapies. [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
- Exhibit differences in response rate of IVIg/SCIg therapies across disease states and demographics [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
- Measure variables within patients who receive IVIg/SCIg therapies [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
This is a prospective, observational evaluation of immunoglobulin (Ig) therapy in consenting PIDD 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, standard-of-care outcome measures, and Ig administration information recorded during normal home infusion visits. There will also be standard-of-care questions captured within some outcome measures recorded during normal home infusion visits that may be at a frequency and/or combination which may not be considered routine clinical care by some physicians who treat for this medical condition. 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: NCT01883921
|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|
|Contact: Timothy Walton, MHS, CCRP 877-342-9352 firstname.lastname@example.org|
|Contact: Sarale Russ, RN, MSN 877-342-9352 email@example.com|
|Principal Investigator:||H James Wedner, MD||Washington University School of Medicine|