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IDEaL — A Landmark Patient Registry Program

The Immunoglobulin, Diagnosis, Evaluation and key Learnings (IDEaL) Patient Registry Program will serve as a platform for epidemiological analyses as well as the development of new therapeutic and treatment care strategies for the population of patients being treated with IVIg and SCIg in the home.

Coram Clinical Trials is proud to sponsor the IDEaL Patient Registry Program.

The IDEaL Patient Registry Program will fill an important niche between formal clinical trials and real world clinical practice, helping to provide an accurate view of the current treatment space.

About IDEaL

The IDEaL Patient Registry is a cooperative, observational registry focused on immunoglobulin (Ig) use in the U.S. The Registry is a deliberate and purposeful assembly of clinical and humanistic knowledge that is intended to act as a longitudinal database, tracking outcomes of routine clinical practice.

In 2011, close to 94,000 patients in the U.S. were treated with approximately 52 million grams of Ig. Diseases requiring Ig therapy are often described as rare, and although these diseases are clinically described in medical literature, there is no comprehensive and well-characterized portrait available of the patient with primary immune deficient and/or immune-mediated neurological disorders.

The Registry's goal is to significantly contribute to the medical understanding of Ig therapy and to improve the quality of care for patients receiving Ig therapy in the U.S. through active publication of Registry findings and disease management approaches.

Data Collection

The data collected will help us gain a better understanding surrounding the therapeutic value of immunoglobulin therapy and subsequently improve practices, reduce medical costs, and ultimately enhance clinical outcomes for the patients we serve. The IDEaL program represents a unique and powerful method for the collection of:

  • Patient-level data: Humanistic information addressing quality of life
  • Physician-level data: Practice patternsƒƒ
  • Clinical data: Therapeutic outcomes
  • Reimbursement data: Impact on treatment and policy decisions

The Registry can help to:

  • Accelerate innovation,
  • Produce faster knowledge gain,
  • Improve awareness of patient outcomes and disease burden, and
  • Provide a clearer understanding of therapy impact on the patients' quality of life.

Registry Objectives

  • To enhance understanding of the variability, progression, and natural history of disease requiring Ig therapy, with the ultimate goal of better guiding and assessing therapeutic intervention.
  • To provide the Ig medical community with recommendations for monitoring patients and to provide reports on patient outcomes to help optimize patient care.ƒƒ
  • To serve as an active knowledge base that can provide population-management information to be used to generate patient-management and practice-management tools.
  • To add to the existing body of knowledge through peer-reviewed manuscripts, scientific abstracts and posters, medical symposia presentations, and patient education.

This study has been registered with ClinicalTrials.gov in accordance with the Food and Drug Administration Amendments Act of 2007.

  • View details of the IDEaL Patient Registry on ClinicalTrials.gov

How to Participate

We are actively seeking physicians to participate as sub-investigators in this landmark patient registry. All physicians who prescribe immunoglobulin therapy are encouraged to participate.

Physician and patient participation are completely voluntary and can be terminated at any time.

The Registry is observational in nature; no change to a patient's medical care is required for participation. Subjects in the Registry will be contacted approximately every six months to complete various quality of life scales.

Critieria for Participation

Patient registries collect data in a comprehensive manner, and therefore produce outcome results that can be generalized to a wide range of patients. They also evaluate care as it is actually provided, because care is not assigned, determined, or even recommended by a protocol. As a result, the outcomes reported are more representative of what is achieved in real-world practice.

A patient registry can be a powerful tool: to observe the course of disease; to understand variations in treatment and outcomes; to examine factors that influence prognosis and quality of life; to describe care patterns, including appropriateness of care and disparities in the delivery of care; to assess effectiveness of care; to monitor safety; and to change behavior through feedback of data.

Inclusion Criteria for Patients

  • Patient is currently receiving Ig therapy
  • Patient agrees to participate in the Registry
  • Patient is on service and receiving care with Coram

Exclusion Criteria for Patients

  • Patient withdraws their participation consent
  • Patient stops service with Coram

Learn More

IDEaL Patient Registry Program
Toll-Free: 800.589.9589
Fax: 949.597.2653
Email: idealpatientregistry@coramhc.com

 

Sean Kearns, PhD
Registry Program Manager
Phone: 303.672.8610
Email: sean.kearns@coramhc.com
Loretta Kristofek
IDEaL Registry Manager
Phone: 321.206.3969
Email: loretta.kristofek@coramhc.com

 

 

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