Trial Outcomes & Findings for STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis (NCT NCT04018495)

NCT ID: NCT04018495

Last Updated: 2025-02-03

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 21 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2025-02-03

Participant Flow

Participant milestones

Measure	CF Patients Using Fitbit for 3 Months 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 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
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

CF Patients Using Fitbit for 3 Months 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 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

Overall Study Physician Decision

1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	CF Patients Using Fitbit for 3 Months n=20 Participants 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 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Measure

CF Patients Using Fitbit for 3 Months n=21 Participants 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 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

Activity Tracker Utilization- Total Days of Use

85.380 Total days used Interval 27.0 to 93.0

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Measure

CF Patients Using Fitbit for 3 Months n=21 Participants 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 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

Activity Tracker Utilization - Minutes of Sleep Per Night

381.28 minutes of sleep per night Interval 0.0 to 983.0

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Measure

CF Patients Using Fitbit for 3 Months n=21 Participants 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 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

Activity Tracker Utilization - Steps Per Day

7262.49 steps/day Interval 0.0 to 30010.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

CF Patients Using Fitbit for 3 Months n=21 Participants 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 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

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

66.535 Percentage of Predicted FEV1 Interval 30.42 to 117.69

Adverse Events

Interventional - Fitbit Tracker

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rose Franco, MD

Medical College of Wisconsin

Phone: 414-955-7040

Email: rfranco@mcw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place