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

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ClinicalTrials.gov Identifier: NCT01883921
Recruitment Status : Recruiting
First Posted : June 21, 2013
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
AxelaCare Health Solutions, LLC

June 19, 2013
June 21, 2013
September 13, 2017
June 2013
June 2018   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01883921 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Response rate for those receiving IVIg/SCIg therapies. [ Time Frame: Up to 5 Years ]
  • Exhibit differences in response rate of IVIg/SCIg therapies across disease states and demographics [ Time Frame: Up to 5 Years ]
  • Measure variables within patients who receive IVIg/SCIg therapies [ Time Frame: Up to 5 Years ]
Same as current
Not Provided
Not Provided
 
Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-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 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.
Primary Immune Deficiency Disorder
Other: Immunoglobulin Therapy
Immunoglobulin Therapy
Intervention: Other: Immunoglobulin Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
Same as current
June 2018
June 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
7 Years and older   (Child, Adult, Older Adult)
No
Contact: Timothy Walton, MHS, CCRP 877-342-9352 twalton@axelacare.com
Contact: Sarale Russ, RN, MSN 877-342-9352 sruss@axelacare.com
United States
 
 
NCT01883921
AHS1-13-002
No
Not Provided
Not Provided
AxelaCare Health Solutions, LLC
AxelaCare Health Solutions, LLC
Not Provided
Not Provided
AxelaCare Health Solutions, LLC
June 2017