Observational Study Comparing Home to Office Spirometry

NCT ID: NCT05285410

Last Updated: 2024-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-30

Study Completion Date

2023-12-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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 without virtually coaching and once with virtually coaching

Exclusion Criteria

* History of lung transplantation
* Initiation of a highly effective modulator therapy within 2 months before Screening Visit
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

University of Arkansas

OTHER

Sponsor Role collaborator

Harvard University

OTHER

Sponsor Role collaborator

Cystic Fibrosis Foundation

OTHER

Sponsor Role collaborator

Chris Goss

OTHER

Sponsor Role lead

Responsible Party

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Chris Goss

Professor of Medicine and Pediatrics, University of Washington

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Margaret Rosenfeld, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington, Seattle Children's Research Institute

Ariel Berlinski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas for Med. Sciences, Arkansas Children's Hospital

Andrea Hartzler, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Greg Sawicki, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Harvard University and Boston Children's Hospital

Locations

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Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Wayne State University Harper University Hospital

Detroit, Michigan, United States

Site Status

Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Site Status

St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status

Lenox Hill Hospital Cystic Fibrosis Center

New York, New York, United States

Site Status

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Children's Hospital Medical Center of Akron

Akron, Ohio, United States

Site Status

Toledo Children's Hospital

Toledo, Ohio, United States

Site Status

Oregon Health Sciences University

Portland, Oregon, United States

Site Status

Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

University of South Carolina School of Medicine

Columbia, South Carolina, United States

Site Status

Sanford USD Medical Center

Sioux Falls, South Dakota, United States

Site Status

The Adult Cystic Fibrosis Center of Central Texas

Austin, Texas, United States

Site Status

Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Providence Medical Group, Cystic Fibrosis Clinic - Pediatrics

Spokane, Washington, United States

Site Status

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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OUTREACH-OB-22

Identifier Type: -

Identifier Source: org_study_id

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