This study will evaluate the performance of wearable technology in cystic fibrosis (CF) participants taking commercial Elexacaftor (ELX)/Tezacaftor (TEZ)/Ivacaftor (IVA) utilizing a fully decentralized trial design.
Study Type
OBSERVATIONAL
Enrollment
51
National Jewish Health
Denver, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Compliance With Actigraphy Wearable Device Measured as Percentage of Time a Participant is Wearing the Actigraphy Wearable Device
Time frame: From Day 1 up to Week 12
Compliance With Cough Measurement Device Measured as Percentage of Time a Participant is Wearing the Cough Measurement Device
Time frame: From Day 1 up to Week 12
Number of Steps per day and Variability in Number of Steps per day Over Time
Number of steps will be reported as mean and variability will be reported as standard deviation (SD).
Time frame: From Day 1 up to Week 12
Number of Coughs per day and Variability in Number of Coughs per day Over Time
Number of coughs will be reported as mean and variability will be reported as SD.
Time frame: From Day 1 up to Week 12
Time Spent Above Sedentary Physical Activity per day and Variability in Time Spent Above Sedentary Physical Activity per day Over Time
Time spent above sedentary physical activity will be reported as mean and variability will be reported as SD.
Time frame: From Day 1 up to Week 12
Time Spent in Moderate-to-Vigorous Physical Activity per day and Variability in Time Spent in Moderate-to-Vigorous Physical Activity per day Over Time
Time spent in moderate-to-vigorous physical activity will be reported as mean and variability will be reported as SD.
Time frame: From Day 1 up to Week 12
Time Spent in Continuous Walking Bouts per day and Variability in Time Spent in Continuous Walking Bouts per day Over Time
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Central Florida Pulmonary Group, P.A.
Orlando, Florida, United States
Children's Hospital of Illinois at OSF Saint Francis Medical Center, Cystic Fibrosis Center
Peoria, Illinois, United States
Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
Mount Sinai Beth Israel
New York, New York, United States
Santiago Reyes, M.D.
Oklahoma City, Oklahoma, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
...and 7 more locations
Time spent in continuous walking bouts will be reported as mean and variability will be reported as SD.
Time frame: From Day 1 up to Week 12
Total Activity Count per day and Variability in Total Activity Count per day Over Time
Total activity count will be reported as mean and variability will be reported as SD.
Time frame: From Day 1 up to Week 12
Best 6-Minute Effort (B6ME) and Variability in B6ME Over Time
B6ME will be reported as mean and variability will be reported as SD.
Time frame: From Day 1 up to Week 12
Sleep Efficiency and Variability in Sleep Efficiency Over Time
Sleep efficiency measurements will be performed using wearable technology which include a wrist-worn actigraphy sensor. Sleep efficiency will be reported as mean and variability will be reported as SD.
Time frame: From Day 1 up to Week 12