Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data (GOOD-SHEPARD)
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Purpose
Primary:
• Demonstrate the utility of a new electronic data capture (EDC) system (CareLogix™) using infusion nurse measured physical, quality of life (QOL), respiratory, and disability assessments.
Secondary:
- 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 |
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Other Conditions That May Be A Focus of Clinical Attention |
| Study Type: | Observational |
| 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 CareLogix™ 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 ]
| Estimated Enrollment: | 1500 |
| 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) |
| Groups/Cohorts |
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Immunoglobulin Therapy
Immunoglobulin Therapy
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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 7 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Children (age ≤ 6 years)
- Prisoners, and other wards of the state
Contacts and Locations| Contact: Timothy Walton, MHS, CCRP | 877-342-9352 | twalton@axelacare.com |
| Contact: Callie Turk, RN, MSN | 877-342-9352 | cturk@axelacare.com |
| United States, Illinois | |
| Northwestern University | Not yet recruiting |
| Chicago, Illinois, United States, 60611 | |
| United States, Kansas | |
| AxelaCare Health Solutions, LLC | Recruiting |
| Lenexa, Kansas, United States, 66219 | |
| Contact: NA | |
| Principal Investigator: | Jeffrey A. Allen, MD | Northwestern University |
More Information
No publications provided
| Responsible Party: | AxelaCare Health Solutions, LLC |
| ClinicalTrials.gov Identifier: | NCT01774331 History of Changes |
| Other Study ID Numbers: | AHS1-12-001 |
| Study First Received: | January 18, 2013 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by AxelaCare Health Solutions, LLC:
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Conditions that require Immunoglobulin therapy. |
Additional relevant MeSH terms:
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Gamma-Globulins Immunoglobulins Antibodies |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013