Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data (GOOD-SHEPARD) (GOOD-SHEPARD)
Verified May 2016 by AxelaCare Health Solutions, LLC
Information provided by (Responsible Party):
AxelaCare Health Solutions, LLC
First received: January 18, 2013
Last updated: May 4, 2016
Last verified: May 2016
• 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
||Observational Model: Cohort
||Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data (GOOD-SHEPARD)
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
Other Outcome Measures:
- 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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| 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.
|Ages Eligible for Study:
||7 Years and older (Child, Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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 AxelaCare Health Solutions, LLC, in collaboration with the patient's prescribing physician. Subjects will be recruited from the practices of participating physicians.
- 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 AxelaCare Health Solutions, LLC. in collaboration with the patient's prescribing physician
- Children (age ≤ 6 years)
- Prisoners, and other wards of the state
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774331
|AxelaCare Health Solutions, LLC
|Lenexa, Kansas, United States, 66219 |
AxelaCare Health Solutions, LLC
||Jeffrey A. Allen, MD
||Northwestern University and University of Minnesota
||AxelaCare Health Solutions, LLC
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 18, 2013
||May 4, 2016
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2016
Rho(D) Immune Globulin
Physiological Effects of Drugs