A Decentralized Study to Evaluate Physical Activity and Cough Frequency Using Wearable Technology in Cystic Fibrosis

Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT04923464
Collaborator
(none)
51
17
5.7
3
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    51 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jun 30, 2021
    Actual Primary Completion Date :
    Dec 20, 2021
    Actual Study Completion Date :
    Dec 20, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. 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]

    2. 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).

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    9. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Jewish Health Denver Colorado United States 80206
    2 Yale New Haven Hospital New Haven Connecticut United States 06510
    3 Central Florida Pulmonary Group, P.A. Orlando Florida United States 32803
    4 Children's Hospital of Illinois at OSF Saint Francis Medical Center, Cystic Fibrosis Center Peoria Illinois United States 61637
    5 Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center Boston Massachusetts United States 02114
    6 Washington University School of Medicine Saint Louis Missouri United States 63110
    7 Morristown Medical Center Morristown New Jersey United States 07960
    8 Mount Sinai Beth Israel New York New York United States 10003
    9 Santiago Reyes, M.D. Oklahoma City Oklahoma United States 73112
    10 UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15224
    11 UW School of Medicine & Public Health Madison Wisconsin United States 53792
    12 Birmingham Heartlands Hospital Birmingham United Kingdom
    13 Royal Devon and Exeter Hospital Exeter United Kingdom
    14 St. James University Hospital Leeds United Kingdom
    15 Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital London United Kingdom
    16 Wythenshawe Hospital Manchester United Kingdom
    17 Southampton General Hospital Southampton United Kingdom

    Sponsors and Collaborators

    • Vertex Pharmaceuticals Incorporated

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vertex Pharmaceuticals Incorporated
    ClinicalTrials.gov Identifier:
    NCT04923464
    Other Study ID Numbers:
    • VX20-445-118
    First Posted:
    Jun 11, 2021
    Last Update Posted:
    Jan 19, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 19, 2022