A Decentralized Study to Evaluate Physical Activity and Cough Frequency Using Wearable Technology in Cystic Fibrosis
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT04923464
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- Forced expiratory volume in 1 second (FEV1) value greater than or equal to (≥) 30 percent predicted
- Participants with an approved CF transmembrane conductance regulator gene (CFTR) genotype according to respective regional labels
Key
- History of solid organ or hematological transplantation
- Non-ambulatory status
Other protocol defined Inclusion/Exclusion criteria may apply
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compliance With Actigraphy Wearable Device Measured as Percentage of Time a Participant is Wearing the Actigraphy Wearable Device From Day 1 up to Week 12
- Secondary Outcome Measures
Name Time Method Compliance With Cough Measurement Device Measured as Percentage of Time a Participant is Wearing the Cough Measurement Device From Day 1 up to Week 12 Number of Steps per day and Variability in Number of Steps per day Over Time From Day 1 up to Week 12 Number of steps will be reported as mean and variability will be reported as standard deviation (SD).
Number of Coughs per day and Variability in Number of Coughs per day Over Time From Day 1 up to Week 12 Number of coughs will be reported as mean and variability will be reported as SD.
Time Spent Above Sedentary Physical Activity per day and Variability in Time Spent Above Sedentary Physical Activity per day Over Time From Day 1 up to Week 12 Time spent above sedentary physical activity will be reported as mean and variability will be reported as SD.
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 From Day 1 up to Week 12 Time spent in moderate-to-vigorous physical activity will be reported as mean and variability will be reported as SD.
Time Spent in Continuous Walking Bouts per day and Variability in Time Spent in Continuous Walking Bouts per day Over Time From Day 1 up to Week 12 Time spent in continuous walking bouts will be reported as mean and variability will be reported as SD.
Total Activity Count per day and Variability in Total Activity Count per day Over Time From Day 1 up to Week 12 Total activity count will be reported as mean and variability will be reported as SD.
Best 6-Minute Effort (B6ME) and Variability in B6ME Over Time From Day 1 up to Week 12 B6ME will be reported as mean and variability will be reported as SD.
Sleep Efficiency and Variability in Sleep Efficiency Over Time From Day 1 up to Week 12 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.
Trial Locations
- Locations (17)
UPMC Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Central Florida Pulmonary Group, P.A.
🇺🇸Orlando, Florida, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital
🇬🇧London, United Kingdom
Children's Hospital of Illinois at OSF Saint Francis Medical Center, Cystic Fibrosis Center
🇺🇸Peoria, Illinois, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center
🇺🇸Boston, Massachusetts, United States
Santiago Reyes, M.D.
🇺🇸Oklahoma City, Oklahoma, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Mount Sinai Beth Israel
🇺🇸New York, New York, United States
Royal Devon and Exeter Hospital
🇬🇧Exeter, United Kingdom
UW School of Medicine & Public Health
🇺🇸Madison, Wisconsin, United States
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
St. James University Hospital
🇬🇧Leeds, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom