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Pulmonary Fibrosis Contact Registry

This study is currently recruiting participants.
Verified August 2013 by Jeff Swigris, National Jewish Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT01935726
First Posted: September 5, 2013
Last Update Posted: November 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Pulmonary Fibrosis Foundation
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Jeff Swigris, National Jewish Health
  Purpose
As the name states, contact registries securely store contact information from groups of reasonably well-characterized patients (or primary supporters/caregivers) who are interested in being informed about ongoing or future research opportunities. Pulmonary fibrosis (PF) is a condition for which effective therapies have remained elusive, making drug trials and interventional research studies a mainstay in the PF arena over the last decade and for the foreseeable future. A PF Contact Registry will be a conduit to collect, analyze, and disseminate de-identified, group-level data on the clinical phenotypes of PF patients and will house contact information from patients who wish to be informed about research opportunities for which they may qualify. Data contained in the Registry will help inform research hypotheses and guide investigators as they develop research protocols by providing them with numbers of potential subjects who meet particular inclusion/exclusion criteria.

Condition
Pulmonary Fibrosis of Any Cause Primary Supporters/Caretakers of Patients With Pulmonary Fibrosis

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: Pulmonary Fibrosis Contact Registry

Resource links provided by NLM:


Further study details as provided by Jeff Swigris, National Jewish Health:

Primary Outcome Measures:
  • Number enrolled [ Time Frame: 20 years ]
    This is a contact registry. We will enroll as many patients and primary supporters/caretakers as possible.


Estimated Enrollment: 50000
Study Start Date: August 2013
Estimated Study Completion Date: January 2040
Estimated Primary Completion Date: January 2040 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pulmonary fibrosis patients or their caretaker/supporter
Patients with pulmonary fibrosis of any cause (idiopathic, related to connective tissue disease [e.g., rheumatoid arthritis, systemic sclerosis/scleroderma, dermato-/polymyositis, sjogren's syndrome], familial or genetic) or the primary supporter/caregiver of a patient with pulmonary fibrosis

Detailed Description:

Detailed information can be found at our website at www.pulmonaryfirbrosisresearch.org.

Who will be in the Registry?

Anyone who is at least 18 years of age, can read and understand English, and either

  1. diagnosed with PF or
  2. a primary supporter or caregiver of someone living with PF

How the Registry works

Patients with PF consent to be enrolled in the Registry and may consent to be contacted by Registry personnel about opportunities for them to participate in research studies. Some of these studies (e.g., "Observing the Effects of Supplemental Oxygen on Patients with Pulmonary Fibrosis") will be conducted by Dr. Swigris and his research team—these studies will be considered Registry-affiliated. Registry participants are free to enroll in any study they wish—whether Registry-affiliated or conducted by investigators not affiliated with the Registry—i.e., non-Registry-affiliated studies. It is assumed the investigators conducting those studies will adhere to regulations governing the protection of human subjects in research. Consider a hypothetical example: an investigator in Michigan is conducting a study of the effects of oral honey on PF-related cough and would like Registry participants to consider enrollment. The investigator would petition the Registry and, if approved by the Registry Oversight Committee, Registry personnel would contact potentially eligible Registry participants to inform them of the study. The participants would then decide whether or not to contact the investigator in Michigan to be considered for enrollment. The investigatory in Michigan would be responsible for discussing the study with any potential subject, obtaining informed consent and conducting the study. All of these fall outside the purview of the Registry or its personnel.

How subjects will enroll in the Registry

Eligible participants must fill out an intake questionnaire/consent form. Contact information provided to receive a questionnaire is not stored by the Registry Data Coordinating Center (DCC) or by the study coordinator. Subjects may obtain the intake questionnaire, complete it, and submit it four different ways:

  • Complete the questionnaire/consent form and submit it online at https://dccweb.njhealth.org/sec/P3F_Swigris/Index.htm. Participants will be encouraged to print a copy for their records.
  • Enter a mailing address onto an online form at http://pulmonaryfibrosisresearch.org/contact and have a hard copy mailed to the subject. Once a signed questionnaire/consent has been sent back to the study coordinator, a copy will be made and mailed back to the participant for his/her records.
  • Fill out the form electronically at https://dccweb.njhealth.org/sec/P3F_Swigris/Index.htm and print a copy of the form, or print the form and fill it out by hand and mail or fax the completed questionnaire to the study coordinator who will then hand it off to the DCC at National Jewish Health. Participants will be encouraged to print a copy for their records.
  • Call the study coordinator toll-free at 1-855-609-0010 and have him/her mail a hard copy of the questionnaire/consent form to the subject. Once a signed questionnaire/consent has been sent back to the study coordinator, a copy will be made and mailed back to the participant for his/her records.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with pulmonary fibrosis of any cause (idiopathic, related to connective tissue disease [e.g., rheumatoid arthritis, systemic sclerosis/scleroderma, dermato-/polymyositis, sjogren's syndrome], familial or genetic) or the primary supporter/caregiver of a patient with pulmonary fibrosis
Criteria

Inclusion Criteria:

  • Anyone who self-reports a diagnosis of pulmonary fibrosis and is over 18 years of age will be included in the Registry.
  • Anyone who self-reports being a primary supporter or caregiver of someone living with pulmonary fibrosis and is over the age of 18 will be included in the Registry.
  • Whoever consents to be enrolled in the Registry will presumably be able to read and write in English.

Exclusion Criteria:

  • Failure to meet inclusion criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935726


Contacts
Contact: Amanda Belkin, MPH 855-609-0010 support@PFresearch.org

Locations
United States, Colorado
National Jewish Health Interstitial Lung Disease Program Recruiting
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Pulmonary Fibrosis Foundation
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Jeff Swigris, DO, MS National Jewish Health
  More Information

Additional Information:
Responsible Party: Jeff Swigris, Associate Professor of Medicine, National Jewish Health
ClinicalTrials.gov Identifier: NCT01935726     History of Changes
Other Study ID Numbers: PCORI 4134
First Submitted: August 31, 2013
First Posted: September 5, 2013
Last Update Posted: November 18, 2014
Last Verified: August 2013

Keywords provided by Jeff Swigris, National Jewish Health:
Pulmonary fibrosis
Interstitial lung disease
Connective tissue disease
Chronic hypersensitivity pneumonitis
Idiopathic pulmonary fibrosis

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases