Pulmonary Fibrosis Contact Registry

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Fibrosis of Any Cause; Primary Supporters/Caretakers of Patients 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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health Interstitial Lung Disease Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number enrolled	This is a contact registry. We will enroll as many patients and primary supporters/caretakers as possible.	20 years

Collaborators and Investigators

• Sponsor: National Jewish Health
• Collaborators: Patient-Centered Outcomes Research Institute; Pulmonary Fibrosis Foundation
• Investigators: Principal Investigator: Jeff Swigris, DO, MS, National Jewish Health

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): March 10, 2019
• Study Completion (Actual): March 10, 2019

Study Registration Dates

• First Submitted: August 31, 2013
• First Submitted That Met QC Criteria: August 31, 2013
• First Posted (Estimate): September 5, 2013

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Idiopathic pulmonary fibrosis; Interstitial lung disease; Pulmonary fibrosis; Connective tissue disease; Chronic hypersensitivity pneumonitis
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis
• Other Study ID Numbers: PCORI 4134