Immunoglobulin, Diagnosis, Evaluation, and Key Learnings Patient Registry (IDEaL™)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

496 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-08

Study Completion Date

2022-06-10

Brief Summary

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The IDEaL registry is a cooperative, observational registry focused on immunoglobulin 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.

The central goal of the registry is to provide a mechanism that allows for a better understanding of how immunoglobulin therapy is being used in a real-world clinical setting. The data gathered will help the industry gain a better understanding surrounding the therapeutic value of immunoglobulin therapy and subsequently improve practices, reduce medical costs, and ultimately improve the clinical outcomes for the patients receiving immunoglobulin therapy

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Detailed Description

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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 United States through active publication of registry findings and disease management approaches.

The IDEaL program represents a unique and powerful method for the collection of:

Patient Level / Humanistic Data / Quality of Life Physician Level / Practice Patterns Clinical Data / Therapeutic Outcomes Reimbursement / Impact on Treatment / Policy Decisions

Whereby:

Accelerating innovation Producing faster knowledge gains Improving awareness of patient outcomes and disease burden Providing a clearer understanding of therapy impact on patients' quality of life.

The objectives of the Registry are:

to enhance the 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; and to serve as an active knowledge base that can provide population-management information, which can be used to generate patient-management and practice-management tools; and

Conditions

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IVIg or SCIg Therapy in the Home or at Alternate Site

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IVIg and SCIg therapy

Patients receiving Ig therapy by IV or SC route in the home or alternate site setting

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Any age, disease, or gender requiring Ig therapy
* Agree to the use of Coram's infusion services after entry into IDEaL Registry

Exclusion Criteria

* Unable to start, or stops taking Ig therapy
* Use of an insurance provider for which Coram's services are not covered/authorized.
* Have previously participated in the IDEaL Registry and revoked consent to use their PHI

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes