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

Study Overview
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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

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

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

Conditions
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IVIg or SCIg Therapy in the Home or at Alternate Site

Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IVIg and SCIg therapy<br>Patients receiving Ig therapy by IV or SC route in the home or alternate site setting | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease by geographic region (and/or Investigative Site), age, therapeutic indication (immunologic/neurologic) | Recorded from referral form | Baseline | 
| Infection incidence by route, dose, and age | Infection incidence, route, dose recorded from Clinical Progress reports Immune Replacement Efficacy section | every 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosing information by disease type, Investigative Site, and therapeutic indication | Dosing collected from Clinical Progress Reports and/or Medication Record | Estimated for baseline and 1 year | 
| Adverse events and serious adverse events by disease type and relation to Ig therapy | Collected from Clinical Progress Reports Therapy Tolerance section | Estimated for baseline and 1 year | 
| IVIg vs SCIg by disease type and geographic region (and/or investigative site) | Route collected from Clinical Progress Reports and/or Medication Record | Baseline | 
| Current state of disease by number of Ig doses received and overall | Ig doses monitored by missed dose section of Clinical Progress Report and Shipping Records | Estimated for 1 year | 
| Payor type by investigator site | Recorded from referral information | Estimated for baseline and 1 year | 
| Insurance reimbursement issues | Obtained when patient has to discharge from study due to insurance change and Coram not a provider | Estimated for baseline and 1 year | 
| Concomitant medication use by disease type and therapeutic indication | Collected from Medication Record | Estimated for baseline and 1 year |