Customer Feedback

AL1TER — A Landmark Patient Registry Program

The Alpha-1 Therapy, Evaluation, and Research (AL1TER) 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 Alpha-1 population.

Coram Clinical Trials is proud to sponsor the AL1TER Patient Registry Program.

The AL1TER 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 the AL1TER Patient Registry

The Alpha-1 Therapy, Evaluation, and Research (AL1TER) Registry is a longitudinal, observational registry for patients diagnosed with Alpha-1 Antitrypsin Deficiency (Alpha-1) who are receiving Alpha-1 Antitrypsin (AAT) augmentation therapy in the home. This deliberate and purposeful assembly of clinical and humanistic knowledge is intended to collect and analyze data related to Alpha-1, especially factors related to initial diagnosis and treatment outcomes.

The Registry's goal is to significantly contribute to the medical understanding of Alpha-1 and to improve the quality of care for patients receiving Alpha-1 augmentation therapy in the U.S. through active publication of Registry findings and disease management approaches.

The AL1TER Registry program represents a unique and powerful method for the collection of:

  • Patient-level data: humanistic information addressing quality of life
  • Physician-level data: practice patterns
  • Clinical data: therapeutic outcomes
  • Reimbursement data: impact on treatment and policy decisions

The AL1TER Registry can help to:

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

Registry Objectives

  • Enhance the understanding of the initial presenation, variability, and progressionof Alpha-1 with the ultimate goal of better guiding and assessing therapeutic intervention;
  • Provide the Alpha-1 medical community with recommendations for monitoring patients and to provide reports on patient outcomes to help optimize patient care;
  • 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
  • Add to the existing body of knowledge through peer-reviewed manuscripts, scientific abstracts and posters, medical symposia presentation, 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 AL1TER 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 screen for Alpha-1, as well as treat Alpha-1 patients, are encouraged to participate.

Physician and patient participation is 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.

Thank you for your interest in the AL1TER Patient Registry Program.

Registry Criteria

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 Alpha-1 augmentation 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

 

 

AL1TER Patient Registry Program
Toll-Free: 800.589.9589
Fax: 949.597.2653
Email: AL1TERpatientregistry@coramhc.com
 
   
Sean Kearns, PhD
Registry Program Manager
Phone: 303.672.8610
Email: sean.kearns@coramhc.com
Loretta Kristofek
Registry Manager
Phone: 321.206.3969
Email: loretta.kristofek@coramhc.com

 

 

CVS Health    CVS Specialty      

Panama City – HHA # 299993869 | Pensacola – HHA # 299993870 | Jacksonville – HHA # 20222096 | Ocala – HHA # 299994092 | Orlando – HHA # 299991256 | Tampa – HHA # 202960961 | Miramar – HHA # 20290096

© Coram LLC