Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by AxelaCare Health Solutions, LLC
Sponsor:
Information provided by (Responsible Party):
AxelaCare Health Solutions, LLC
ClinicalTrials.gov Identifier:
NCT01883921
First received: June 19, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.

Condition Intervention
Primary Immune Deficiency Disorder
Other: Immunoglobulin Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Analysis of collected data captured in CareExchange™ -ability to show and track changes in outcome data in PIDD patients. [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician feedback will demonstrate if having real-time access to patient data captured during a home infusion will assist in the management of the patient's disease. [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
  • Response rate for those receiving IVIg/SCIg therapies. [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
  • Exhibit differences in response rate of IVIg/SCIg therapies across disease states and demographics [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
  • Measure variables within patients who receive IVIg/SCIg therapies [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: June 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Immunoglobulin Therapy Other: Immunoglobulin Therapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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 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:

  • 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
  Contacts and Locations
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: NCT01883921

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: Timothy Walton, MHS, CCRP    877-342-9352    twalton@axelacare.com   
Contact: Callie Turk, RN, MSN    877-342-9352    cturk@axelacare.com   
United States, Missouri
Washington University School of Medicine Not yet recruiting
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
AxelaCare Health Solutions, LLC
Investigators
Principal Investigator: H James Wedner, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: AxelaCare Health Solutions, LLC
ClinicalTrials.gov Identifier: NCT01883921     History of Changes
Other Study ID Numbers: AHS1-13-002
Study First Received: June 19, 2013
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by AxelaCare Health Solutions, LLC:
Primary Immunodeficiency
Immunodeficiencies
Primary Immunodeficiency Diseases
Common Variable Immunodeficiency
Immunodeficiency
PIDD
CVID
PI
Hypogammaglobulinemia
Acquired Hypogammaglobulinemia
Immunology
Autoimmune Deficiency
Intravenous Immunoglobulin
Subcutaneous Immunoglobulin
IVIg
SCIg
Immune Globulin
Outcomes Research

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases
Gamma-Globulins
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014