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Completed

NCT Number: NCT05285410

Observational Study Comparing Home to Office Spirometry

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Providence Alaska Medical Center, Anchorage, Alaska, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Difference (bias) in home spirometry compared to office spirometry for 12-week forced expiratory volume in 1 second (FEV1) (% predicted) change

    Time frame: 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)

  2. Analytic efficiency of home versus office spirometry for 12-week FEV1 (% predicted) change

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chris Goss

Other

Collaborators

  • Cystic Fibrosis Foundation
  • Harvard University
  • University of Arkansas
  • University of Washington

Registry information

Official study title

Observational Study of Telehealth for Remote Endpoint Assessment (OUTREACH)

Acronym: OUTREACH

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 17, 2022
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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