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

This study is currently recruiting participants.
Verified July 2013 by AxelaCare Health Solutions, LLC
Sponsor:
Information provided by (Responsible Party):
AxelaCare Health Solutions, LLC
ClinicalTrials.gov Identifier:
NCT01774331
First received: January 18, 2013
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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
Intravenous Immunoglobulin (IVIg) Therapy in a Home Infusion Setting

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)

Further study details as provided by AxelaCare Health Solutions, LLC:

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: 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
Immunoglobulin Therapy
Immunoglobulin Therapy

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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774331

Contacts
Contact: Timothy Walton, MHS, CCRP 877-342-9352 twalton@axelacare.com
Contact: Callie Turk, RN, MSN 877-342-9352 cturk@axelacare.com

Locations
United States, Kansas
AxelaCare Health Solutions, LLC Recruiting
Lenexa, Kansas, United States, 66219
Contact: NA         
Sponsors and Collaborators
AxelaCare Health Solutions, LLC
Investigators
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: July 10, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gamma-Globulins
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014