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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Cystic fibrosis patients seen at an academic adult CF center.
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| Name | Affiliation | Role |
|---|---|---|
| Rose Franco, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin/Froedtert Hospital | Milwaukee | Wisconsin | 53202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16162729 | Background | 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. | |
| 29087960 | 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. |
| Label | URL |
|---|---|
| Sample size requirements for estimating Pearson, Kendall and Spearman Correlations. Insufficient sleep is a public health problem. Cystic Fibrosis Trust Cystic Fibrosis Registry Report | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Full Range | Total days used | 3 months |
|
3 months
the device used is generally available to the public and is not expected to cause any adverse health events. Subjects were informed to communicate if they had any concerns related to the device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interventional - 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 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rose Franco, MD | Medical College of Wisconsin | 414-955-7040 | rfranco@mcw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2020 | Nov 16, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2020 | Oct 25, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| 11936530 | 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. |
| 26158896 | 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. |
| 10898125 | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Activity Tracker Utilization - Minutes of Sleep Per Night | Descriptive statistics, such as mean for the number of minutes per sleep per night | Posted | Mean | Full Range | minutes of sleep per night | 3 months |
|
|
|
| Primary | Activity Tracker Utilization - Steps Per Day | Descriptive statistics, such as mean, for the number of steps per day | Posted | Mean | Full Range | steps/day | 3 months |
|
|
|
| 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. | Posted | Mean | Full Range | Percentage of Predicted FEV1 | 3 months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |