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| ID | Type | Description | Link |
|---|---|---|---|
| 1OT2HD108111-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose of this study is to compare COVID-19 knowledge, experiences, and health behaviors between participants who received the health initiative and those who did not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Education Initiative | Experimental | Participants will receive the health education session for up to 6 months. |
|
| Control Group | No Intervention | Participants in this group will not receive any health education and total participation is up to 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Education Initiative | Behavioral | Participants will receive a one time 45 minute intervention session. During the session participants will receive information regarding COVID-19 disease process and behavioral effects and had the opportunity to ask questions. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Acceptability of Intervention as Measured by Acceptability Questionnaire | Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating more knowledge, value, application, or satisfaction. Evaluation was collected directly after the intervention, at baseline. | Baseline |
| Evaluation of Confidence in COVID Healthcare Decision Making as Measured by COVID Confidence Questionnaire | Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating more knowledge, value, application, or satisfaction. | 6 months |
| Number of Caregivers Who Received COVID-19 Vaccine | The unit of measure is the number of caregivers who received COVID-19 vaccine at baseline | Baseline |
| Number of Children Who Received COVID-19 Vaccine | unit of measure number of children | Baseline |
| Health Behaviors as Measured by Health Behavior Questionnaire | Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating greater intent to engage in health behaviors to prevent COVID-19. | Baseline |
| Number of Caregivers Who Received COVID-19 Vaccine | The unit of measure is the number of caregivers who received COVID-19 vaccine | 6 months |
| Health Behaviors as Measured by Health Behavior Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD as Measured by the University of California Los Angeles (UCLA) Brief COVID-19 Screen for Child/Adolescent Post Traumatic Stress Disorder (PTSD) | Individual item scores range from 0 to 4, individual total sum scores range from 0 to 44 higher scores indicate more symptoms of PTSD. Total sum score ranging from 1-10 is considered "minimal PTSD", total sum score ranging from 11-20 is considered "mild PTSD", total sum scores of 21 or more is considered "potential PTSD". |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Gwynn, DO | University of Miami | Principal Investigator |
| Elizabeth Pulgaron, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Health Education Initiative | Participants will receive the health education session for up to 6 months. Health Education Initiative: Participants will receive a one time 45 minute intervention session. During the session participants will receive information regarding COVID-19 disease process and behavioral effects and had the opportunity to ask questions. |
| FG001 | Control Group | Participants in this group will not receive any health education and total participation is up to 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline measures including age, sex, ethnicity and race were optional for participants to report.
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| ID | Title | Description |
|---|---|---|
| BG000 | Health Education Initiative | Participants will receive the health education session for up to 6 months. Health Education Initiative: Participants will receive a one time 45 minute intervention session. During the session participants will receive information regarding COVID-19 disease process and behavioral effects and had the opportunity to ask questions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | There were only 64 participants analyzed because the remaining participants did not respond to the question. |
| 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 | Evaluation of Acceptability of Intervention as Measured by Acceptability Questionnaire | Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating more knowledge, value, application, or satisfaction. Evaluation was collected directly after the intervention, at baseline. | This was data collection only for the health education initiative. The control group did not participate in this section. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
6 months
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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 | Health Education Initiative | Participants will receive the health education session for up to 6 months. Health Education Initiative: Participants will receive a one time 45 minute intervention session. During the session participants will receive information regarding COVID-19 disease process and behavioral effects and had the opportunity to ask questions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Gwynn | University of Miami | 305-243-3440 | LGwynn@med.miami.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 25, 2025 | Jun 10, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 5, 2022 | May 20, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating greater intent to engage in health behaviors to prevent COVID-19. |
| 6 month |
| Number of Children Who Received COVID-19 Vaccine | unit of measure number of children | 6 months |
| Baseline, 6 month follow up |
| COVID Anxiety as Measured by the Coronavirus Anxiety Scale | individual item score ranges from 0 to 4, individual total sum scores range from 0 to 20 higher scores indicate more symptoms of COVID specific anxiety. Total sum scores of greater than of equal to 9 equals "probable dysfunctional Coronavirus related anxiety". | Baseline, 6 month follow up |
| BG001 |
| Control Group |
Participants in this group will not receive any health education and total participation is up to 6 months. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | There were only 65 participants analyzed, because the remaining participants did not respond to the question. | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants |
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|
|
| Primary | Evaluation of Confidence in COVID Healthcare Decision Making as Measured by COVID Confidence Questionnaire | Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating more knowledge, value, application, or satisfaction. | This was only administered to the intervention group. No control participants were analyzed because they did not receive this measure. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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|
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| Primary | Number of Caregivers Who Received COVID-19 Vaccine | The unit of measure is the number of caregivers who received COVID-19 vaccine at baseline | The number of participants analyzed at 6 months is lower than those who were analyzed at baseline due to participants lost to follow-up. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Number of Children Who Received COVID-19 Vaccine | unit of measure number of children | The number of participants analyzed at baseline differs from the number analyzed at 6 months because participants were lost to follow-up. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Health Behaviors as Measured by Health Behavior Questionnaire | Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating greater intent to engage in health behaviors to prevent COVID-19. | The number of participants analyzed differ between baseline and 6 months because participants were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Number of Caregivers Who Received COVID-19 Vaccine | The unit of measure is the number of caregivers who received COVID-19 vaccine | The number of participants analyzed at 6 months is lower than those who were analyzed at baseline due to participants lost to follow-up. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | Health Behaviors as Measured by Health Behavior Questionnaire | Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating greater intent to engage in health behaviors to prevent COVID-19. | The number of participants analyzed differ between baseline and 6 months because participants were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 6 month |
|
|
|
| Secondary | PTSD as Measured by the University of California Los Angeles (UCLA) Brief COVID-19 Screen for Child/Adolescent Post Traumatic Stress Disorder (PTSD) | Individual item scores range from 0 to 4, individual total sum scores range from 0 to 44 higher scores indicate more symptoms of PTSD. Total sum score ranging from 1-10 is considered "minimal PTSD", total sum score ranging from 11-20 is considered "mild PTSD", total sum scores of 21 or more is considered "potential PTSD". | The number of participants analyzed at baseline is lower than the overall number of participants, because some participants did not complete their packet of questionnaires, including the present measure. There were fewer participants at the 6-month follow-up because participants were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 month follow up |
|
|
|
| Secondary | COVID Anxiety as Measured by the Coronavirus Anxiety Scale | individual item score ranges from 0 to 4, individual total sum scores range from 0 to 20 higher scores indicate more symptoms of COVID specific anxiety. Total sum scores of greater than of equal to 9 equals "probable dysfunctional Coronavirus related anxiety". | The number of participants analyzed at baseline is lower than the overall number of participants, because some participants did not complete their packet of questionnaires, including the present measure. There were fewer participants at the 6-month follow-up because participants were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 month follow up |
|
|
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| Primary | Number of Children Who Received COVID-19 Vaccine | unit of measure number of children | The number of participants analyzed at baseline differs from the number analyzed at 6 months because participants were lost to follow-up. | Posted | Count of Participants | Participants | 6 months |
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| 0 |
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | Control Group | Participants in this group will not receive any health education and total participation is up to 6 months. | 0 | 36 | 0 | 36 | 0 | 36 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 6 month follow up |
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| 6 month follow up |
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