Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 7 - Any |
| Updated: | 1/31/2019 |
| Start Date: | June 2013 |
| End Date: | June 2020 |
| Contact: | Timothy Walton, MHS, CCRP |
| Email: | twalton@axelacare.com |
| Phone: | 877-342-9352 |
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)
Primary:
- 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).
Secondary:
- 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.
- 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).
Secondary:
- 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.
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.
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.
Inclusion Criteria:
- Diagnosis of any form of Primary Immunodeficiency Disease
- 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 Ig under the discretion of the patient's treating physician in accordance
with standard treatment practices
- Have been on or is between doses of Ig under the discretion of the patient's treating
physician in accordance with standard treatment practices
- Being considered to be prescribed Ig under the discretion of the patient's treating
physician in accordance with standard treatment practices
- Determined to be 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
- Determined to have non-competency of data collection requirements (physical
assessments and use of an iPAD™) by the study participant's caregiver
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