Clinical trial NCT04923464: A Decentralized Study to Evaluate Physical Activity and Cough Frequency Using Wearable Technology in Cystic Fibrosis
Official title: A Phase 4 Decentralized Pilot Study With Wearable Technology in Cystic Fibrosis Subjects 18 Years of Age and Older Taking Commercial Elexacaftor/Tezacaftor/Ivacaftor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2021-06-11
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with CF taking commercial ELX/TEZ/IVA will be enrolled in the study.

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.


Eligibility criteria: Key Inclusion Criteria:

* 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 Exclusion Criteria:

* History of solid organ or hematological transplantation
* Non-ambulatory status

Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Compliance With Actigraphy Wearable Device Measured as Percentage of Time a Participant is Wearing the Actigraphy Wearable Device
timeFrame: From Day 1 up to Week 12
Secondary outcomes:
measure: Compliance With Cough Measurement Device Measured as Percentage of Time a Participant is Wearing the Cough Measurement Device
timeFrame: From Day 1 up to Week 12
measure: Number of Steps per day and Variability in Number of Steps per day Over Time
timeFrame: From Day 1 up to Week 12
measure: Number of Coughs per day and Variability in Number of Coughs per day Over Time
timeFrame: From Day 1 up to Week 12
measure: Time Spent Above Sedentary Physical Activity per day and Variability in Time Spent Above Sedentary Physical Activity per day Over Time
timeFrame: From Day 1 up to Week 12
measure: 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
timeFrame: From Day 1 up to Week 12
measure: Time Spent in Continuous Walking Bouts per day and Variability in Time Spent in Continuous Walking Bouts per day Over Time
timeFrame: From Day 1 up to Week 12
measure: Total Activity Count per day and Variability in Total Activity Count per day Over Time
timeFrame: From Day 1 up to Week 12
measure: Best 6-Minute Effort (B6ME) and Variability in B6ME Over Time
timeFrame: From Day 1 up to Week 12
measure: Sleep Efficiency and Variability in Sleep Efficiency Over Time
timeFrame: From Day 1 up to Week 12
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Orlando
country: United States
facility: Central Florida Pulmonary Group, P.A.
state: Florida
city: Peoria
country: United States
facility: Children's Hospital of Illinois at OSF Saint Francis Medical Center, Cystic Fibrosis Center
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: Oklahoma City
country: United States
facility: Santiago Reyes, M.D.
state: Oklahoma
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Madison
country: United States
facility: UW School of Medicine & Public Health
state: Wisconsin
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
city: Leeds
country: United Kingdom
facility: St. James University Hospital
city: London
country: United Kingdom
facility: Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
References: