A Decentralized Study to Evaluate Physical Activity and Cough Frequency Using Wearable Technology in Cystic Fibrosis
A Phase 4 Decentralized Pilot Study With Wearable Technology in Cystic Fibrosis Subjects 18 Years of Age and Older Taking Commercial Elexacaftor/Tezacaftor/Ivacaftor
1 other identifier
observational
51
2 countries
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2021
Shorter than P25 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2021
CompletedFirst Posted
Study publicly available on registry
June 11, 2021
CompletedStudy Start
First participant enrolled
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2021
CompletedJanuary 19, 2022
January 1, 2022
6 months
May 20, 2021
January 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
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 Coughs per day and Variability in Number of Coughs per day Over Time
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
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
From Day 1 up to Week 12
- +4 more secondary outcomes
Study Arms (1)
ELX/TEZ/IVA
CF participants who are currently on a stable regimen of commercially available ELX/TEZ/IVA will be evaluated for the performance of wearable technology devices. Wearable devices include a wrist-worn actigraphy sensor and an ambulatory cough monitoring system.
Eligibility Criteria
Participants with CF taking commercial ELX/TEZ/IVA will be enrolled in the study.
You may qualify if:
- 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
You may not qualify if:
- History of solid organ or hematological transplantation
- Non-ambulatory status
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
National Jewish Health
Denver, Colorado, 80206, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Central Florida Pulmonary Group, P.A.
Orlando, Florida, 32803, United States
Children's Hospital of Illinois at OSF Saint Francis Medical Center, Cystic Fibrosis Center
Peoria, Illinois, 61637, United States
Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center
Boston, Massachusetts, 02114, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Mount Sinai Beth Israel
New York, New York, 10003, United States
Santiago Reyes, M.D.
Oklahoma City, Oklahoma, 73112, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
UW School of Medicine & Public Health
Madison, Wisconsin, 53792, United States
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
St. James University Hospital
Leeds, United Kingdom
Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital
London, United Kingdom
Wythenshawe Hospital
Manchester, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2021
First Posted
June 11, 2021
Study Start
June 30, 2021
Primary Completion
December 20, 2021
Study Completion
December 20, 2021
Last Updated
January 19, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing