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

NCT04018495 | Completed Results

• 1 other identifier: 34812
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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)

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (3)

• Activity Tracker Utilization- Total Days of Use

  Descriptive statistics, such as mean for the number of days of use over the three month period

  3 months

• Activity Tracker Utilization - Minutes of Sleep Per Night

  Descriptive statistics, such as mean for the number of minutes per sleep per night

  3 months

• Activity Tracker Utilization - Steps Per Day

  Descriptive statistics, such as mean, for the number of steps per day

  3 months

Secondary Outcomes (1)

• Integration of Cystic Fibrosis Registry Lung Function Data - Average GLI FEV1 From First to Last Day of Fitbit Wear

  3 months

Study Arms (1)

CF patients using Fitbit for 3 months

CF patients at time of enrollment who are willing to use a fitbit tracker to measure activity and sleep during the observational period of 3 months.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cystic fibrosis patients seen at an academic adult CF center.

You may qualify if:

• Adults with Cystic Fibrosis
• Age \>18, Cystic Fibrosis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, 53202, United States

Location

Related Publications (5)

• 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.

  PMID: 16162729 BACKGROUND

• 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.

  PMID: 29087960 BACKGROUND

• 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.

  PMID: 11936530 BACKGROUND

• 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.

  PMID: 26158896 BACKGROUND

• 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.

  PMID: 10898125 BACKGROUND

Related Links

• Sample size requirements for estimating Pearson, Kendall and Spearman Correlations. Insufficient sleep is a public health problem. Cystic Fibrosis Trust Cystic Fibrosis Registry Report

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Results Point of Contact

• Title: Rose Franco, MD
• Organization: Medical College of Wisconsin

rfranco@mcw.edu

414-955-7040

Study Officials

• Rose Franco, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: September 10, 2019
• Primary Completion: August 24, 2022
• Study Completion: August 24, 2022
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)