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

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Completed
CT.gov ID
NCT04018495
Collaborator
Cystic Fibrosis Foundation (Other)
21
1
1
35.4
0.6

Study Details

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
  • Device: Fitbit Tracker
N/A

Study Design

Study Type:
Interventional
Actual 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 :
Sep 10, 2019
Actual Primary Completion Date :
Aug 24, 2022
Actual Study Completion Date :
Aug 24, 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 [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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 Medical College of Wisconsin/Froedtert Hospital Milwaukee Wisconsin United States 53202

Sponsors and Collaborators

  • Medical College of Wisconsin
  • Cystic Fibrosis Foundation

Investigators

  • Principal Investigator: Rose Franco, MD, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Rose Franco, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT04018495
Other Study ID Numbers:
  • 34812
First Posted:
Jul 12, 2019
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2022