STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis
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 |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
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Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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.
- 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.
- 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
Inclusion Criteria:
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Adults with Cystic Fibrosis
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Age >18, Cystic Fibrosis
Exclusion Criteria:
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A potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.
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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.
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Those patients without dedicated access to a smartphone, tablet, or computer with internet for syncing device and completing patient diary.
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Those patients unwilling to sign an informed consent form.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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
- 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.
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