Coram Clinical Trials
Centennial, Colorado, 80112, United States
NCT Number: NCT01109810
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
Looking for future studies?
Notify MeAll sexes
Observational
Centennial, Colorado, 80112, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Recorded from referral form
Time frame: every 6 months
Infection incidence, route, dose recorded from Clinical Progress reports Immune Replacement Efficacy section
Time frame: Estimated for baseline and 1 year
Dosing collected from Clinical Progress Reports and/or Medication Record
Time frame: Estimated for baseline and 1 year
Collected from Clinical Progress Reports Therapy Tolerance section
Time frame: Baseline
Route collected from Clinical Progress Reports and/or Medication Record
Time frame: Estimated for 1 year
Ig doses monitored by missed dose section of Clinical Progress Report and Shipping Records
Time frame: Estimated for baseline and 1 year
Recorded from referral information
Time frame: Estimated for baseline and 1 year
Obtained when patient has to discharge from study due to insurance change and Coram not a provider
Time frame: Estimated for baseline and 1 year
Collected from Medication Record
Coram Clinical Trials
Other
Acronym: IDEaL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.