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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitbit Tracker
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cystic Fibrosis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical College of Wisconsin/Froedtert Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional - Fitbit tracker

Arm Description

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

Outcomes

Primary Outcome Measures

Participants will Consistently Use Fitbit Tracker
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

Integration Tool Development
Develop integration tool for the data from the Fitbit with data from Cystic Fibrosis Foundation Patient Registry.

Full Information

First Posted
July 9, 2019
Last Updated
August 23, 2022
Sponsor
Medical College of Wisconsin
Collaborators
Cystic Fibrosis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04018495
Brief Title
STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis
Official Title
STimulating ImProved Health And Well-being In CysTic Fibrosis Using Integration Of Fitness Technology and Port CF.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
August 24, 2022 (Actual)
Study Completion Date
August 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Cystic Fibrosis Foundation

4. Oversight

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
Data Monitoring Committee
No

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional - Fitbit tracker
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Fitbit Tracker
Intervention Description
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 Measure Information:
Title
Participants will Consistently Use Fitbit Tracker
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Integration Tool Development
Description
Develop integration tool for the data from the Fitbit with data from Cystic Fibrosis Foundation Patient Registry.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Trends of FEV1 will be measured
Description
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.
Time Frame
1 year
Title
Trends of BMI will be measured
Description
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.
Time Frame
1 year
Title
Trends exacerbation rates will be measured
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rose Franco, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin/Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16162729
Citation
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. doi: 10.1378/chest.128.3.1357.
Results Reference
background
PubMed Identifier
29087960
Citation
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.
Results Reference
background
PubMed Identifier
11936530
Citation
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. doi: 10.1183/09031936.02.00088702.
Results Reference
background
PubMed Identifier
26158896
Citation
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.
Results Reference
background
PubMed Identifier
10898125
Citation
Gonzalez-Ortiz M, Martinez-Abundis E, Balcazar-Munoz BR, Pascoe-Gonzalez S. Effect of sleep deprivation on insulin sensitivity and cortisol concentration in healthy subjects. Diabetes Nutr Metab. 2000 Apr;13(2):80-3.
Results Reference
background
Links:
URL
http://www.cysticfibrosis.org.uk/the-work-we-do/uk-cf-registry/reporting-and-resources
Description
Sample size requirements for estimating Pearson, Kendall and Spearman Correlations. Insufficient sleep is a public health problem. Cystic Fibrosis Trust Cystic Fibrosis Registry Report

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

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