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| Name | Class |
|---|---|
| University of Washington | OTHER |
| University of Arkansas | OTHER |
| Harvard University | OTHER |
| Cystic Fibrosis Foundation |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | Week 0 to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Study participants will be recruited at Cystic Fibrosis Foundation's Therapeutics Development Network study sites
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Rosenfeld, MD, MPH | University of Washington, Seattle Children's Research Institute | Principal Investigator |
| Ariel Berlinski, MD | University of Arkansas for Med. Sciences, Arkansas Children's Hospital | Principal Investigator |
| Andrea Hartzler, PhD | University of Washington | Principal Investigator |
| Greg Sawicki, MD, MPH | Harvard University and Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | United States | ||
| Arkansas Children's Hospital |
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| OTHER |
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| Little Rock |
| Arkansas |
| 72202 |
| United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Wayne State University Harper University Hospital | Detroit | Michigan | 48201 | United States |
| Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49546 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Lenox Hill Hospital Cystic Fibrosis Center | New York | New York | 10003 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | United States |
| Toledo Children's Hospital | Toledo | Ohio | 43606 | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| University of South Carolina School of Medicine | Columbia | South Carolina | 29203 | United States |
| Sanford USD Medical Center | Sioux Falls | South Dakota | 57117 | United States |
| The Adult Cystic Fibrosis Center of Central Texas | Austin | Texas | 78705 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Providence Medical Group, Cystic Fibrosis Clinic - Pediatrics | Spokane | Washington | 99204 | United States |
| Froedtert & Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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