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Completed

NCT Number: NCT04018495

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

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)

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, 53202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Activity Tracker Utilization- Total Days of Use

    Time frame: 3 months

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

  2. Activity Tracker Utilization - Minutes of Sleep Per Night

    Time frame: 3 months

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

  3. Activity Tracker Utilization - Steps Per Day

    Time frame: 3 months

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

Secondary outcomes

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

    Time frame: 3 months

    Analyze the data trends. Forced Expiratory Volume (FEV1) reported will be used for small group analysis to compare trends with lung function mean from first to last day of wear.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

STimulating ImProved Health And Well-being In CysTic Fibrosis Using Integration Of Fitness Technology and Port CF.

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2019
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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