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To determine the accuracy and precision of capillary refill time measurement using a mobile health application (Cap App) in a healthy pediatric population. This will be a cross-sectional study measuring the capillary refill time in a healthy pediatric population using both the Cap App and two additional manual methods which will serve as the comparison.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Health application (CapApp) | Device | Mobile Health application (CapApp) will be used to measure capillary refill time in a healthy pediatric population and compared to two additional manual methods to include both human and computer annotation and mobile health application (Cap App). |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy and Precision of a Mobile Health Application (Cap App) | Capillary refill time (CRT) of Cap App compared to two manual methods | Time it takes for blood to return to issue on the fingertip after pressure application for 5 seconds |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy children age 1 month to 17 years
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
There are no plans on sharing results of the individual participant study data or aggregate study data with the participants. The data will be kept blinded from the research team members at the time of collection and, thus, no information will be shared with the participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mobile Health Application | Mobile Health application (CapApp) will be used to measure capillary refill time in a healthy pediatric population and compared to two additional manual methods to include both human and computer annotation and mobile health application (Cap App). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mobile Health Application | Mobile Health application (CapApp) will be used to measure capillary refill time in a healthy pediatric population and compared to two additional manual methods to include both human and computer annotation and mobile health application (Cap App). |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Accuracy and Precision of a Mobile Health Application (Cap App) | Capillary refill time (CRT) of Cap App compared to two manual methods | Posted | Mean | Standard Deviation | seconds | Time it takes for blood to return to issue on the fingertip after pressure application for 5 seconds |
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Data on adverse events was not collected
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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 | Mobile Health Application | Mobile Health application (CapApp) will be used to measure capillary refill time in a healthy pediatric population and compared to two additional manual methods to include both human and computer annotation and mobile health application (Cap App). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Strutt | University of Minnesota | (314) 578-8045 | strutt@umn.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 | Oct 27, 2022 | May 17, 2024 | Prot_SAP_000.pdf |
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| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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