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| ID | Type | Description | Link |
|---|---|---|---|
| 1KL2TR002554 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The purpose of this study is to develop and evaluate a tool designed to help parents make decisions about childhood vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Childhood vaccination decision support tool | Experimental | Participants receive childhood vaccination decision support tool |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Childhood vaccination decision support tool | Other | Participants receive childhood vaccination decision support tool |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire | Study specific questionnaire comprised of 10 True or False questions. Knowledge was measured on a score of 0-10, where a higher score indicates a greater level of knowledge. Outcome reports on the difference in the knowledge score measure pre- and post- exposure to intervention. | pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline) |
| Change in Acceptability of Childhood Vaccinations | pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lavanya Vasudevan, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Childhood Vaccination Decision Support Tool | Participants receive childhood vaccination decision support tool Childhood vaccination decision support tool: Participants receive childhood vaccination decision support tool |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Childhood Vaccination Decision Support Tool | Participants receive childhood vaccination decision support tool Childhood vaccination decision support tool: Participants receive childhood vaccination decision support tool |
| 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, 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 | Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire | Study specific questionnaire comprised of 10 True or False questions. Knowledge was measured on a score of 0-10, where a higher score indicates a greater level of knowledge. Outcome reports on the difference in the knowledge score measure pre- and post- exposure to intervention. | Participants who completed both questionnaires. | Posted | Mean | Standard Deviation | score on a scale | pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline) |
|
Approximately 4-6 weeks
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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 | Childhood Vaccination Decision Support Tool | Participants receive childhood vaccination decision support tool Childhood vaccination decision support tool: Participants receive childhood vaccination decision support tool |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lavanya Vasudevan, Ph.D., M.P.H., C.P.H. | Emory University | 404-727-3956 | lavanya.vasudevan@emory.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 | Feb 16, 2023 | Mar 14, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 10, 2021 | Jul 12, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000072758 | Vaccination Refusal |
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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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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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Change in Acceptability of Childhood Vaccinations | Data not collected. | Posted | pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline) |
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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