An interventional study of Health Education Initiative in COVID-19, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by University of Miami · Not applicable, Interventional, and Health services research
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 112 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Miami is the lead sponsor of 821 studies on the registry; 162 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Participants will receive the health education session for up to 6 months.
Behavioral: Health Education Initiative
Participants in this group will not receive any health education and total participation is up to 6 months.
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.
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.
Time frame: 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.
Time frame: 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
Time frame: Baseline
Number of Children Who Received COVID-19 Vaccine
unit of measure number of children
Time frame: 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.
Time frame: Baseline
Number of Caregivers Who Received COVID-19 Vaccine
The unit of measure is the number of caregivers who received COVID-19 vaccine
Time frame: 6 months
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.
Time frame: 6 month
Number of Children Who Received COVID-19 Vaccine
unit of measure number of children
Time frame: 6 months
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".
Time frame: 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".
Time frame: Baseline, 6 month follow up
| Milestone | Health Education Initiative | Control Group |
|---|---|---|
| Started | 76 | 36 |
| Completed | 20 | 18 |
| Not completed | 56 | 18 |
| Withdrew: Lost to follow-up | 56 | 18 |
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.
| score on a scale | Health Education Initiative |
|---|---|
| Evaluation of Acceptability of Intervention as Measured by Acceptability Questionnaire | 4.47 ± 0.89 |
Scores range from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating more knowledge, value, application, or satisfaction.
| score on a scale | Health Education Initiative |
|---|---|
| Evaluation of Confidence in COVID Healthcare Decision Making as Measured by COVID Confidence Questionnaire | 4.38 ± 0.86 |
The unit of measure is the number of caregivers who received COVID-19 vaccine at baseline
| Participants | Health Education Initiative | Control Group |
|---|---|---|
| Number of Caregivers Who Received COVID-19 Vaccine | 35 | 24 |
unit of measure number of children
| Participants | Health Education Initiative | Control Group |
|---|---|---|
| Number of Children Who Received COVID-19 Vaccine | 23 | 18 |
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.
| score on a scale | Health Education Initiative | Control Group |
|---|---|---|
| Health Behaviors as Measured by Health Behavior Questionnaire | 4.10 ± 1.10 | 3.76 ± 1.37 |
The unit of measure is the number of caregivers who received COVID-19 vaccine
| Participants | Health Education Initiative | Control Group |
|---|---|---|
| Number of Caregivers Who Received COVID-19 Vaccine | 18 | 7 |
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.
| score on a scale | Health Education Initiative | Control Group |
|---|---|---|
| Health Behaviors as Measured by Health Behavior Questionnaire | 4.09 ± 0.82 | 3.96 ± 1.18 |
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".
| score on a scale | Health Education Initiative | Control Group |
|---|---|---|
| Baseline | 5.83 ± 6.49 | 5.77 ± 8.63 |
| 6 month follow up | 4.6 ± 6.7 | 7.74 ± 8.27 |
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".
| score on a scale | Health Education Initiative | Control Group |
|---|---|---|
| Baseline | 0.21 ± 0.62 | 1.37 ± 3.95 |
| 6 month follow up | 0.83 ± 2.28 | 0.42 ± 1.22 |
unit of measure number of children
| Participants | Health Education Initiative | Control Group |
|---|---|---|
| Number of Children Who Received COVID-19 Vaccine | 11 | 5 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Health Education Initiative | 0/76 (0%) | 0/76 (0%) | 0/76 (0%) |
| Control Group | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
Baseline measures including age, sex, ethnicity and race were optional for participants to report.
| Age, Continuous(years) | Health Education Initiative | Control Group | Total |
|---|---|---|---|
| Mean | 44.34 ± 8.80 | 41.69 ± 7.85 | 42.89 ± 8.14 |
| Sex: Female, Male(Participants) | Health Education Initiative | Control Group | Total |
|---|---|---|---|
| Female | 26 | 32 | 58 |
| Male | 3 | 4 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Health Education Initiative | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 5 | 12 |
| Not Hispanic or Latino | 17 | 31 | 48 |
| Unknown or Not Reported | 52 | 0 | 52 |
| Race (NIH/OMB)(Participants) | Health Education Initiative | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 18 | 28 | 46 |
| White | 8 | 5 | 13 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 49 | 2 | 51 |
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