Observational Study Comparing Home to Office Spirometry

Cystic Fibrosis Clinical Trial

— OUTREACH  

Official title:

Observational Study of Telehealth for Remote Endpoint Assessment (OUTREACH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05285410
• Other study ID #: OUTREACH-OB-22
• Status: Completed
• Start date: November 30, 2022
• Est. completion date: December 19, 2023

Study information

• Verified date: January 2024
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
United States	Children's Hospital Medical Center of Akron	Akron	Ohio
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	The Adult Cystic Fibrosis Center of Central Texas	Austin	Texas
United States	Boston Children's Hospital	Boston	Massachusetts
United States	University of South Carolina School of Medicine	Columbia	South Carolina
United States	Wayne State University Harper University Hospital	Detroit	Michigan
United States	Helen DeVos Children's Hospital	Grand Rapids	Michigan
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Froedtert & Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Lenox Hill Hospital Cystic Fibrosis Center	New York	New York
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Oregon Health Sciences University	Portland	Oregon
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Seattle Children's Hospital	Seattle	Washington
United States	Sanford USD Medical Center	Sioux Falls	South Dakota
United States	Providence Medical Group, Cystic Fibrosis Clinic - Pediatrics	Spokane	Washington
United States	Toledo Children's Hospital	Toledo	Ohio
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (5)

Lead Sponsor	Collaborator
Chris Goss	Cystic Fibrosis Foundation, Harvard University, University of Arkansas, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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