Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04018495
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Rose Franco, Medical College of Wisconsin

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018495


Contacts
Layout table for location contacts
Contact: Jeanette Graf, BS 414-955-6987 jgraf@mcw.edu
Contact: Erin Hubertz, BS 414-955-7019 ehubertz@mcw.edu

Locations
Layout table for location information
United States, Wisconsin
Medical College of Wisconsin/Froedtert Hospital Recruiting
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

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Rose Franco, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04018495     History of Changes
Other Study ID Numbers: 34812
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases