免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis

STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis

Study Description
Brief Summary:
STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis Using Integration Of Fitness Technology and Port CF. A pilot in integration of wearable fitness tracker data with existing health data provided by CF foundation Patient Registry (Port CF)

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Device: Fitbit Tracker Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: STimulating ImProved Health And Well-being In CysTic Fibrosis Using Integration Of Fitness Technology and Port CF.
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Interventional - Fitbit tracker
Fitbit tracker; is an activity tracking product that is wireless-enabled wearable technology device that measures data such as the number of steps walked, heart rate, quality of sleep, steps climbed, and other personal metrics involved in fitness
 Device: Fitbit Tracker
Fitbit tracker; is an activity tracking product that is wireless-enabled wearable technology device that measures data such as the number of steps walked, heart rate, quality of sleep, steps climbed, and other personal metrics involved in fitness
Outcome Measures
Primary Outcome Measures :
  1. Participants will Consistently Use Fitbit Tracker [ Time Frame: 1 year ]
    Demonstrate that participants will consistently use and upload data from the fitness tracker as measured by use of at least 20 hours per day and uploading of at least 75% of activity.


Secondary Outcome Measures :
  1. Integration Tool Development [ Time Frame: 1 year ]
    Develop integration tool for the data from the Fitbit with data from Cystic Fibrosis Foundation Patient Registry.


Other Outcome Measures:
  1. Trends of FEV1 will be measured [ Time Frame: 1 year ]
    Analyze the data trends from the Fitbit for activity and sleep with health trends from the CFFPR. Forced Expiratory Volume (FEV1) will be measured pre and post use of Fitbit.

  2. Trends of BMI will be measured [ Time Frame: 1 year ]
    Analyze the data trends from the Fitbit for activity and sleep with health trends from the CFFPR. Body mass index (BMI) per pounds will be measured pre and post Fitbit.

  3. Trends exacerbation rates will be measured [ Time Frame: 1 year ]
    Analyze the data trends from the Fitbit for activity and sleep with health trends from the CFFPR. Exacerbation symptoms and rates will be measured pre and post Fitbit.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with Cystic Fibrosis
  • Age >18, Cystic Fibrosis

Exclusion Criteria:

  • A potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.
  • Those unable to commit to at least 3 months follow up for CF care from enrollment at study CF center. Inability to speak and understand English.
  • Those patients without dedicated access to a smartphone, tablet, or computer with internet for syncing device and completing patient diary.
  • Those patients unwilling to sign an informed consent form.
Contacts and Locations

Locations
Layout table for location information
United States, Wisconsin
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States, 53202
Sponsors and Collaborators
Medical College of Wisconsin
Cystic Fibrosis Foundation
Investigators
Layout table for investigator information
Principal Investigator: Rose Franco, MD Medical College of Wisconsin
Tracking Information
First Submitted Date  ICMJE July 9, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date October 30, 2020
Actual Study Start Date  ICMJE September 10, 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019) 		Participants will Consistently Use Fitbit Tracker [ Time Frame: 1 year ]
Demonstrate that participants will consistently use and upload data from the fitness tracker as measured by use of at least 20 hours per day and uploading of at least 75% of activity.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019) 		Integration Tool Development [ Time Frame: 1 year ]
Develop integration tool for the data from the Fitbit with data from Cystic Fibrosis Foundation Patient Registry.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2019)
  • Trends of FEV1 will be measured [ Time Frame: 1 year ]
    Analyze the data trends from the Fitbit for activity and sleep with health trends from the CFFPR. Forced Expiratory Volume (FEV1) will be measured pre and post use of Fitbit.
  • Trends of BMI will be measured [ Time Frame: 1 year ]
    Analyze the data trends from the Fitbit for activity and sleep with health trends from the CFFPR. Body mass index (BMI) per pounds will be measured pre and post Fitbit.
  • Trends exacerbation rates will be measured [ Time Frame: 1 year ]
    Analyze the data trends from the Fitbit for activity and sleep with health trends from the CFFPR. Exacerbation symptoms and rates will be measured pre and post Fitbit.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis
Official Title  ICMJE STimulating ImProved Health And Well-being In CysTic Fibrosis Using Integration Of Fitness Technology and Port CF.
Brief Summary STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis Using Integration Of Fitness Technology and Port CF. A pilot in integration of wearable fitness tracker data with existing health data provided by CF foundation Patient Registry (Port CF)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE Device: Fitbit Tracker
Fitbit tracker; is an activity tracking product that is wireless-enabled wearable technology device that measures data such as the number of steps walked, heart rate, quality of sleep, steps climbed, and other personal metrics involved in fitness
Study Arms  ICMJE Experimental: Interventional - Fitbit tracker
Fitbit tracker; is an activity tracking product that is wireless-enabled wearable technology device that measures data such as the number of steps walked, heart rate, quality of sleep, steps climbed, and other personal metrics involved in fitness
Intervention: Device: Fitbit Tracker
Publications *
  • Amin R, Bean J, Burklow K, Jeffries J. The relationship between sleep disturbance and pulmonary function in stable pediatric cystic fibrosis patients. Chest. 2005 Sep;128(3):1357-63.
  • Beattie Z, Oyang Y, Statan A, Ghoreyshi A, Pantelopoulos A, Russell A, Heneghan C. Estimation of sleep stages in a healthy adult population from optical plethysmography and accelerometer signals. Physiol Meas. 2017 Oct 31;38(11):1968-1979. doi: 10.1088/1361-6579/aa9047.
  • Dancey DR, Tullis ED, Heslegrave R, Thornley K, Hanly PJ. Sleep quality and daytime function in adults with cystic fibrosis and severe lung disease. Eur Respir J. 2002 Mar;19(3):504-10.
  • de Zambotti M, Baker FC, Colrain IM. Validation of Sleep-Tracking Technology Compared with Polysomnography in Adolescents. Sleep. 2015 Sep 1;38(9):1461-8. doi: 10.5665/sleep.4990.
  • González-Ortiz M, Martínez-Abundis E, Balcázar-Muñoz BR, Pascoe-González S. Effect of sleep deprivation on insulin sensitivity and cortisol concentration in healthy subjects. Diabetes Nutr Metab. 2000 Apr;13(2):80-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2019) 		21
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults with Cystic Fibrosis
  • Age >18, Cystic Fibrosis

Exclusion Criteria:

  • A potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.
  • Those unable to commit to at least 3 months follow up for CF care from enrollment at study CF center. Inability to speak and understand English.
  • Those patients without dedicated access to a smartphone, tablet, or computer with internet for syncing device and completing patient diary.
  • Those patients unwilling to sign an informed consent form.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04018495
Other Study ID Numbers  ICMJE 34812
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rose Franco, Medical College of Wisconsin
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE Cystic Fibrosis Foundation
Investigators  ICMJE
Principal Investigator: Rose Franco, MD Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯