Clinical trial NCT05285410: Observational Study Comparing Home to Office Spirometry
Official title: Observational Study of Telehealth for Remote Endpoint Assessment (OUTREACH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Telehealth
Spirometry
Cystic Fibrosis
CF
Telemedicine
ZEPHYRx
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
name: University of Arkansas
name: Harvard University
name: Cystic Fibrosis Foundation
First posted: 2022-03-17
Enrollment: 116
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be recruited at Cystic Fibrosis Foundation's Therapeutics Development Network study sites

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference (bias) in home spirometry compared to office spirometry for 12-week forced expiratory volume in 1 second (FEV1) (% predicted) change
timeFrame: Week 0 to Week 12
measure: Analytic efficiency of home versus office spirometry for 12-week FEV1 (% predicted) change
timeFrame: Week 0 to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University Harper University Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Helen DeVos Children's Hospital
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: New York
country: United States
facility: Lenox Hill Hospital Cystic Fibrosis Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Akron
country: United States
facility: Children's Hospital Medical Center of Akron
state: Ohio
city: Toledo
country: United States
facility: Toledo Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: Jefferson University Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: University of South Carolina School of Medicine
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
city: Austin
country: United States
facility: The Adult Cystic Fibrosis Center of Central Texas
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Spokane
country: United States
facility: Providence Medical Group, Cystic Fibrosis Clinic - Pediatrics
state: Washington
city: Milwaukee
country: United States
facility: Froedtert & Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Washington, Seattle Children's Research Institute
name: Margaret Rosenfeld, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arkansas for Med. Sciences, Arkansas Children's Hospital
name: Ariel Berlinski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Andrea Hartzler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard University and Boston Children's Hospital
name: Greg Sawicki, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: