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Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data (GOOD-SHEPARD) (GOOD-SHEPARD)

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ClinicalTrials.gov Identifier: NCT01774331
Recruitment Status : Recruiting
First Posted : January 24, 2013
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
AxelaCare Health Solutions, LLC

Brief Summary:

Primary:

• 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.

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 or disease
Intravenous Immunoglobulin (IVIg) Therapy in a Home Infusion Setting

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.

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data (GOOD-SHEPARD)
Study Start Date : November 2012
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Group/Cohort
Immunoglobulin Therapy
Immunoglobulin Therapy



Primary Outcome Measures :
  1. Analysis of collected data captured in CareExchange™ will demonstrate the ability to show and track changes in outcome data. [ Time Frame: 5 Years ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. Demonstration of response rate for those receiving IVIg. [ Time Frame: 5 Years ]
  2. Exhibit differences in response rate of IVIg therapy across disease states and demographics. [ Time Frame: 5 Years ]
  3. Demonstration of measured variables within patients who receive IVIg. [ Time Frame: 5 Years ]


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Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774331


Contacts
Contact: Timothy Walton, MHS, CCRP 877-342-9352 twalton@axelacare.com

Locations
United States, Kansas
AxelaCare Health Solutions, LLC Recruiting
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
AxelaCare Health Solutions, LLC
Investigators
Principal Investigator: Jeffrey A. Allen, MD Northwestern University and University of Minnesota

Responsible Party: AxelaCare Health Solutions, LLC
ClinicalTrials.gov Identifier: NCT01774331     History of Changes
Other Study ID Numbers: AHS1-12-001
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Immunoglobulins
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs