Observational Study Comparing Home to Office Spirometry

Chris Goss116 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

116

Conditions

Cystic Fibrosis

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Locations (19)

Providence Alaska Medical Center

Anchorage, Alaska, United States

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: Week 0 to Week 12

Data from ClinicalTrials.gov

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