Cystic Fibrosis
Conditions
Keywords
Telehealth, Spirometry, Cystic Fibrosis, CF, Telemedicine, ZEPHYRx
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.
Interventions
None listed
Sponsors
University of Washington
University of Arkansas
Harvard University
Cystic Fibrosis Foundation
Chris Goss
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference (bias) in home spirometry compared to office spirometry for 12-week forced expiratory volume in 1 second (FEV1) (% predicted) change | Week 0 to Week 12 | Difference between home and office spirometry estimates of FEV1 (% predicted) change from Week 0 to Week 12 (home estimate - office estimate) |
| Analytic efficiency of home versus office spirometry for 12-week FEV1 (% predicted) change | Week 0 to Week 12 | Factor by which trial sample size must increase/decrease to maintain a given power going from office to home spirometry |
Countries
United States
Outcome results
None listed