Observational Study Comparing Home to Office Spirometry

NCT05285410 | Completed

• 1 other identifier: OUTREACH-OB-22
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Cystic Fibrosis

Keywords

Telehealth; Spirometry; Cystic Fibrosis; CF; Telemedicine; ZEPHYRx

Outcome Measures

Primary Outcomes (2)

• Difference (bias) in home spirometry compared to office spirometry for 12-week forced expiratory volume in 1 second (FEV1) (% predicted) change

  Difference between home and office spirometry estimates of FEV1 (% predicted) change from Week 0 to Week 12 (home estimate - office estimate)

  Week 0 to Week 12

• Analytic efficiency of home versus office spirometry for 12-week FEV1 (% predicted) change

  Factor by which trial sample size must increase/decrease to maintain a given power going from office to home spirometry

  Week 0 to Week 12

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be recruited at Cystic Fibrosis Foundation's Therapeutics Development Network study sites

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chris Goss: lead
• University of Washington: collaborator
• University of Arkansas: collaborator
• Harvard University: collaborator
• Cystic Fibrosis Foundation: collaborator

Study Sites (19)

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Wayne State University Harper University Hospital

Detroit, Michigan, 48201, United States

Location

Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49546, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Lenox Hill Hospital Cystic Fibrosis Center

New York, New York, 10003, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Toledo Children's Hospital

Toledo, Ohio, 43606, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of South Carolina School of Medicine

Columbia, South Carolina, 29203, United States

Location

Sanford USD Medical Center

Sioux Falls, South Dakota, 57117, United States

Location

The Adult Cystic Fibrosis Center of Central Texas

Austin, Texas, 78705, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Providence Medical Group, Cystic Fibrosis Clinic - Pediatrics

Spokane, Washington, 99204, United States

Location

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Margaret Rosenfeld, MD, MPH

  University of Washington, Seattle Children's Research Institute

  PRINCIPAL INVESTIGATOR

• Ariel Berlinski, MD

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

  PRINCIPAL INVESTIGATOR

• Andrea Hartzler, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Greg Sawicki, MD, MPH

  Harvard University and Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine and Pediatrics, University of Washington

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: November 30, 2022
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

US (19)