Pulmonary Fibrosis Contact Registry
Condition: Pulmonary Fibrosis of Any Cause; Primary Supporters/Caretakers of Patients With Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Fibrosis
Study type: Observational [Patient Registry]

Summary: 
      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.
    

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.
    

Observational model: Other
Time perspective: Prospective
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
      
Keywords: Pulmonary fibrosis; Interstitial lung disease; Connective tissue disease; Chronic hypersensitivity pneumonitis; Idiopathic pulmonary fibrosis