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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001111 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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Cardiac rehabilitation participants will be enrolled during cardiac rehabilitation and provided an activity tracker to use.
Cardiac rehabilitation participants will be enrolled during cardiac rehabilitation and provided an activity tracker to use. Each week they will be provided a summary report of their steps and physical activity, that will continue to 6 weeks post discharge from cardiac rehabilitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activity Tracker | Experimental | Participants provided an activity tracker to wear and weekly reports |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activity Tracker | Behavioral | Individually tailored daily and weekly physical activity goals established for all participants. Participants sent weekly reports for 6 weeks after cardiac rehabilitation discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Steps Per Day (Preintervention Period) | Average steps per day measured by the activity tracker | pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks |
| Average Physical Activity in Minutes Per Day (Preintervention Period) | Average "very active" minutes per day of physical activity measured by the activity tracker | pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks |
| Average Steps Per Day (Intervention Period) | Average steps per day measured by the activity tracker | Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks |
| Average Physical Activity in Minutes Per Day (Intervention Period) | Average "very active" minutes per day of physical activity measured by the activity tracker | Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks |
| Average Steps Per Day (Maintenance Period) | Average steps per day measured by the activity tracker | Maintenance (day following when the last weekly report was sent to last day of tracking by staff), a total of up to 15 weeks |
| Average Physical Activity Per Day (Maintenance Period) | Average "very active" minutes per day of physical activity measured by the activity tracker |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Evenson, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
Time Frame: Deidentified individual data that supports the activity tracker results may be shared from 0-12 months following publication.
Access Criteria: An investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.
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| ID | Title | Description |
|---|---|---|
| FG000 | Activity Tracker | Participants provided an activity tracker to wear and weekly reports Activity Tracker: Individually tailored daily and weekly physical activity goals established for all participants. Participants sent weekly reports for 6 weeks after cardiac rehabilitation discharge. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Activity Tracker | Participants provided an activity tracker to wear and weekly reports Activity Tracker: Individually tailored daily and weekly physical activity goals established for all participants. Participants sent weekly reports for 6 weeks after cardiac rehabilitation discharge. |
| 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 | Average Steps Per Day (Preintervention Period) | Average steps per day measured by the activity tracker | One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker). | Posted | Mean | Full Range | steps per day | pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks |
|
From the time of enrollment (approximately 4 weeks prior to cardiac rehabilitation discharge) through 6 weeks post cardiac rehabilitation discharge.
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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 | Activity Tracker | Participants provided an activity tracker to wear and weekly reports Activity Tracker: Individually tailored daily and weekly physical activity goals established for all participants. Participants sent weekly reports for 6 weeks after cardiac rehabilitation discharge. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Evenson, PhD | University of North Carolina at Chapel Hill | (919) 966-1967 | kelly_evenson@unc.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 | May 10, 2019 | Jun 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072936 | Fitness Trackers |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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This is a pilot study. All participants receive the intervention.
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|
| Maintenance (day following when the last weekly report was sent to last day of tracking by staff), an overall total of up to 15 weeks |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Average Physical Activity in Minutes Per Day (Preintervention Period) | Average "very active" minutes per day of physical activity measured by the activity tracker | One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker). | Posted | Mean | Full Range | minutes per day | pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks |
|
|
|
| Primary | Average Steps Per Day (Intervention Period) | Average steps per day measured by the activity tracker | One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker). | Posted | Mean | Full Range | steps per day | Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks |
|
|
|
| Primary | Average Physical Activity in Minutes Per Day (Intervention Period) | Average "very active" minutes per day of physical activity measured by the activity tracker | One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker). | Posted | Mean | Full Range | minutes per day | Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks |
|
|
|
| Primary | Average Steps Per Day (Maintenance Period) | Average steps per day measured by the activity tracker | One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker). | Posted | Mean | Full Range | steps per day | Maintenance (day following when the last weekly report was sent to last day of tracking by staff), a total of up to 15 weeks |
|
|
|
| Primary | Average Physical Activity Per Day (Maintenance Period) | Average "very active" minutes per day of physical activity measured by the activity tracker | One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker). | Posted | Mean | Full Range | minutes per day | Maintenance (day following when the last weekly report was sent to last day of tracking by staff), an overall total of up to 15 weeks |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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