Cystic Fibrosis
Conditions
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.
Interventions
None listed
Sponsors
Cystic Fibrosis Foundation
Medical College of Wisconsin
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Adults with Cystic Fibrosis * Age \>18, Cystic Fibrosis
Exclusion criteria
* A potential subject who meets any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activity Tracker Utilization- Total Days of Use | 3 months | Descriptive statistics, such as mean for the number of days of use over the three month period |
| Activity Tracker Utilization - Minutes of Sleep Per Night | 3 months | Descriptive statistics, such as mean for the number of minutes per sleep per night |
| Activity Tracker Utilization - Steps Per Day | 3 months | Descriptive statistics, such as mean, for the number of steps per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Integration of Cystic Fibrosis Registry Lung Function Data - Average GLI FEV1 From First to Last Day of Fitbit Wear | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | CF Patients Using Fitbit for 3 Months |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 33 years STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Activity Tracker Utilization - Minutes of Sleep Per Night
Descriptive statistics, such as mean for the number of minutes per sleep per night
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CF Patients Using Fitbit for 3 Months | Activity Tracker Utilization - Minutes of Sleep Per Night | 381.28 minutes of sleep per night |
Primary
Activity Tracker Utilization - Steps Per Day
Descriptive statistics, such as mean, for the number of steps per day
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CF Patients Using Fitbit for 3 Months | Activity Tracker Utilization - Steps Per Day | 7262.49 steps/day |
Primary
Activity Tracker Utilization- Total Days of Use
Descriptive statistics, such as mean for the number of days of use over the three month period
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CF Patients Using Fitbit for 3 Months | Activity Tracker Utilization- Total Days of Use | 85.380 Total days used |
Secondary
Integration of Cystic Fibrosis Registry Lung Function Data - Average GLI FEV1 From First to Last Day of Fitbit Wear
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CF Patients Using Fitbit for 3 Months | 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 |