Observational Study of Telehealth for Remote Endpoint Assessment (OUTREACH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 19
- 主要终点
- Analytic efficiency of home versus office spirometry for 12-week FEV1 (% predicted) change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •History of lung transplantation
- •Initiation of a highly effective modulator therapy within 2 months before Screening Visit
结局指标
主要结局
Analytic efficiency of home versus office spirometry for 12-week FEV1 (% predicted) change
时间窗: 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
Difference (bias) in home spirometry compared to office spirometry for 12-week forced expiratory volume in 1 second (FEV1) (% predicted) change
时间窗: 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)
次要结局
未报告次要终点
研究者
Chris Goss
Professor of Medicine and Pediatrics, University of Washington
Seattle Children's Hospital