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Pulmonary Fibrosis Foundation Community Registry

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05382572
Collaborator
Pulmonary Fibrosis Foundation (Other)
10,000
Enrollment
1
Location
35.7
Anticipated Duration (Months)
280.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pulmonary fibrosis (PF) results from a diverse group of health conditions and affects the lives of patients (including those who are post lung transplant), caregivers and family members. The Pulmonary Fibrosis Foundation Community Registry will offer an online portal where participants can self-enroll and directly contribute information about their experience with PF to be compiled into a longitudinal data set for use by researchers.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The PFF Community Registry is an observational, longitudinal cohort study. The Community

    Registry will enroll three different cohort groups:

    1. Patients with PF, including those who are post lung transplant

    2. Caregivers of patients with PF

    3. Family members of patients with PF

    This is an online registry open to individuals affected by PF in the US. It is not associated with a physical location or institution. Individuals may self-enroll online and contribute data to the Community Registry by answering a series of surveys at regular intervals.

    Participants may also elect to be contacted about future research projects through the PFF Community Registry portal. However, this is not required to participate in the Community Registry itself.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pulmonary Fibrosis Foundation Community Registry
    Actual Study Start Date :
    Jul 11, 2022
    Anticipated Primary Completion Date :
    Jul 1, 2025
    Anticipated Study Completion Date :
    Jul 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Patients

    An individual diagnosed with PF or ILD, including those who are post lung transplant.
    Family Members

    A family member (defined as biological parent, full or half-sibling, or biological child) of an individual with PF or ILD.
    Caregivers

    An individual who has cared (currently or in the past) for an individual with PF or ILD.

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients who have or had interstitial lung disease (ILD) enrolled in the PFF Community Registry [3 years]

    2. Number of caregivers of patients who have or had ILD enrolled in the PFF Community Registry [3 years]

    3. Number of family members of patients who have or had ILD enrolled in the PFF Community Registry [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    In order to be eligible to participate in this study, an individual must meet all of the following criteria:

    1. Provision of signed and dated informed consent form online

    2. Male or female, aged 18 or older

    3. Affected by PF as a member of at least one of the following cohorts:

    4. An individual diagnosed with PF or ILD, including those who are post lung transplant, or

    5. An individual who has cared (currently or in the past) for an individual with PF or ILD, and / or

    6. A family member (defined as parent, full or half-sibling, or child) of an individual with PF or ILD.

    7. Has internet access and a valid email address.

    Exclusion Criteria:

    An individual who meets any of the following criteria will be excluded from participation in this study:

    1. Primary residence or place of care is outside of the US.

    2. Inability or unwillingness of a participant to provide informed consent or comply with study protocol.

    3. Any condition or circumstance not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

    4. Patients who were diagnosed with any of the below lung diseases. Similarly caregivers and family members associated with these diseases would be excluded.

    • Sarcoid

    • Lymphangioleiomyomatosis (LAM)

    • Pulmonary alveolar proteinosis (PAP)

    • Cystic fibrosis (CF)

    • Amyloidosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pulmonary Fibrosis Foundation Chicago Illinois United States 60611

    Sponsors and Collaborators

    • University of Michigan
    • Pulmonary Fibrosis Foundation

    Investigators

    • Study Chair: Kevin R Flaherty, MD, University of Michigan
    • Principal Investigator: Cathie Spino, ScD, University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Cathie Spino, ScD, Research Professor, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT05382572
    Other Study ID Numbers:
    • HUM00202724
    First Posted:
    May 19, 2022
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Diseases
    Pulmonary Fibrosis
    Idiopathic Pulmonary Fibrosis
    Lung Diseases, Interstitial
    Fibrosis

    Study Results

    No Results Posted as of Jul 22, 2022