Clinical trial NCT04018495: 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: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2019-07-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cystic fibrosis patients seen at an academic adult CF center.

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: Cystic fibrosis patients who are willing to use an activity tracker for 3 months are invited to participate. Analysis of activity patterns and sleep patterns will be analyzed and compared to their lung function and general health as part of the routine CF center care visits during the study period.

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.

Primary outcomes:
measure: Activity Tracker Utilization- Total Days of Use
timeFrame: 3 months
measure: Activity Tracker Utilization - Minutes of Sleep Per Night
timeFrame: 3 months
measure: Activity Tracker Utilization - Steps Per Day
timeFrame: 3 months
Secondary outcomes:
measure: Integration of Cystic Fibrosis Registry Lung Function Data - Average GLI FEV1 From First to Last Day of Fitbit Wear
timeFrame: 3 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin/Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Rose Franco, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.