Observational Study Comparing Home to Office Spirometry

Last updated: January 10, 2024
Sponsor: Chris Goss
Overall Status: Completed

Phase

N/A

Condition

Cystic Fibrosis

Lung Disease

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT05285410
OUTREACH-OB-22
  • Ages > 6
  • All Genders

Study Summary

This is a prospective, longitudinal multicenter observational study comparing home to office spirometry and home to office weight and height measurements. The aim of the study is to estimate the accuracy and variability of home spirometric measurements over time, and to assess the feasibility and acceptability of home measurements.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documentation of a CF diagnosis
  • Clinically stable
  • ≥6 years of age at Screening Visit
  • During the run-in period, performed acceptable home spirometry at least twice withoutvirtually coaching and once with virtually coaching

Exclusion

Exclusion Criteria:

  • History of lung transplantation
  • Initiation of a highly effective modulator therapy within 2 months before ScreeningVisit

Study Design

Total Participants: 116
Study Start date:
November 30, 2022
Estimated Completion Date:
December 19, 2023

Study Description

After successful completion of the run-in period, participants will have 3 in-person visits, at which office spirometry will be performed and weight and height measured. Participants will perform home spirometry weekly during the study period. They will also electronically complete a weekly electronic patient reported outcome (ePRO) Within one week of each in-person visit, they will measure height and weight at home and perform home spirometry with virtual coaching by site research staff. They will complete a brief ePRO every 4 weeks regarding acceptability and feasibility of home spirometry in research. Within two weeks after study completion, a purposive subsample will complete an exit interview.

Connect with a study center

  • Providence Alaska Medical Center

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • University of California at Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • OSF Saint Francis Medical Center

    Peoria, Illinois 61637
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Wayne State University Harper University Hospital

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Helen DeVos Children's Hospital

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • St. Louis Children's Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Lenox Hill Hospital Cystic Fibrosis Center

    New York, New York 10003
    United States

    Site Not Available

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Children's Hospital Medical Center of Akron

    Akron, Ohio 44308
    United States

    Site Not Available

  • Toledo Children's Hospital

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Oregon Health Sciences University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of South Carolina School of Medicine

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Sanford USD Medical Center

    Sioux Falls, South Dakota 57117
    United States

    Site Not Available

  • The Adult Cystic Fibrosis Center of Central Texas

    Austin, Texas 78705
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

  • Providence Medical Group, Cystic Fibrosis Clinic - Pediatrics

    Spokane, Washington 99204
    United States

    Site Not Available

  • Froedtert & Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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