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Conduct a pilot study to test feasibility of doing remote data collection with a point of care device that measures HbA1c.
The foundation for cardiovascular health (CVH) is laid in early life by intergenerational interactions, passed from parent to child, that have long-lasting biological and behavioral consequences. Lifestyle interventions can promote CVH among mothers and their children over time. Academic partnerships with home visiting organizations that reach families experiencing health disparities advance intergenerational CVH equity. For this pilot study we are testing the feasibility of doing remote data collection with a point of care device that measures HbA1c to use in the main study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point of care device to measure HbA1c | Diagnostic Test | After consent the participant will meet with the research team virtually to obtain HbA1c. The HbA1c self check equipment will be sent to the participant. During the video call the research team will talk the participant through obtaining their HbA1c with the point of care device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility to Obtain HbA1c Through Remote Data Collection | Feasibility will be measured by how many participants are able to obtain HbA1c measure through remote data collection and participant's satisfaction with this means of data collection. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
-
For the participants only women will be included: Including only female participants is scientifically justified, as the main study focus is addressing cardiovascular health of prenatal and postpartum women.
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Pregnant or postpartum women who are currently or have recently participated in the Parents as Teachers home visiting program.
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| Name | Affiliation | Role |
|---|---|---|
| Debra Haire-Joshu, PhD | Washington University School of Medicine | Principal Investigator |
| Victor G Davila-Roman, MD,FACC,FASE | Washington University School of Medicine | Principal Investigator |
| Rachel G Tabak, PhD, RD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63130 | United States |
Only data with identifiers removed will be shared publicly. Any identified data to be shared will only be done so in coordination with the Human Research Protection Office at Washington University in St. Louis and the Institutional Review Board (IRB) at the requesting investigator's institution.
Datasets with identifiers will only be accessible to study team members with appropriate Human Subjects training.
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| ID | Title | Description |
|---|---|---|
| FG000 | Point of Care Device | Test the feasibility of doing remote data collection with a point of care device that measures HbA1c. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Point of Care Device | Test the feasibility of doing remote data collection with a point of care device that measures HbA1c. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Feasibility to Obtain HbA1c Through Remote Data Collection | Feasibility will be measured by how many participants are able to obtain HbA1c measure through remote data collection and participant's satisfaction with this means of data collection. | Posted | Count of Participants | Participants | Baseline |
|
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Adverse events were collected during the data collection visit, about 20 minutes.
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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 | Point of Care Device | Participants were asked to test the feasibility and rate the acceptability of using the point of care device. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cindy Schwarz | Washington University in St. Louis | 314-935-3063 | cschwarz@wustl.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | May 16, 2025 | May 20, 2025 | Prot_ICF_000.pdf |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
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