NCT05285410

Observational Study Comparing Home to Office Spirometry

Observational Study of Telehealth for Remote Endpoint Assessment (OUTREACH)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 116 (actual)
• Sponsor: Chris Goss · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis

Timeline

• Start date: 2022-11-30
• Primary completion: 2023-12-19
• Completion: 2023-12-19
• First posted: 2022-03-17
• Last updated: 2024-01-11

Locations

19 sites across 1 country: United States