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| ID | Type | Description | Link |
|---|---|---|---|
| P50MD017349 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The goal of this clinical trial is to learn if using point-of-care ultrasound (POCUS) can increase participant engagement and changes in behavior among adults with risk factors for pre-symptomatic heart failure presenting to the emergency department. The main questions it aims to answer are:
Researchers will compare an educational intervention with versus without POCUS to see if POCUS works to improve outcomes.
Participants will:
Receive either the educational intervention alone or an educational intervention plus POCUS. They will report the difference in their understanding and likelihood to improve diet, exercise, and follow up immediately post-intervention. They will also report changes in diet, exercise, follow up, and self-efficacy at three months post-intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational Intervention Alone | Placebo Comparator |
| |
| Ultrasound and Educational Intervention | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound and Educational Intervention | Other | This will include the educational intervention combined with a point-of-care ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Primary Care Follow Up | Defined as the presence or absence of a follow up visit with a primary care provider at 3 months | 3 Months Post-Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Likelihood to Follow Up with a Primary Care Physician within the 3 Months Post-Intervention | Ordinal scale of 1 (very unlikely) to 7 (very likely) | Baseline and Immediately Post-Intervention |
| Self-perceived knowledge of heart failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aylin Ornelas Loredo, MMS | Contact | 312-563-0645 | aylin_a_ornelasloredo@rush.edu | |
| Michelle Santangelo, MS | Contact | 312-563-0645 | michelle_santangelo@rush.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Gottlieb, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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| Educational Intervention Alone | Other | This will include only the educational intervention (without ultrasound) |
|
Ordinal scale of 1 (no knowledge) to 7 (extremely knowledgeable)
| Baseline and Immediately Post-Intervention |
| Degree of motivation and self-efficacy using a modified High Blood Pressure Self-Care Profile (HBP-SCP) Motivation and Self-Efficacy tool | Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention |
| Likelihood to change their fruit and vegetable intake using the Stages of Change tools for Fruits and Vegetables | Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention |
| Likelihood to change their fat intake using the Stages of Change for Dietary Fat tool | Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention |
| Likelihood to change their exercise using the Stages of Change for Physical Activity | Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention |
| Change in diet quality using the Mediterranean Eating Pattern for Americans tool | Baseline and 3 Months Post-Intervention |
| Change in exercise status using the Exercise Vital Sign tool | Baseline and 3 Months Post-Intervention |
| Satisfaction with the educational intervention | Ordinal scale of 1 (very unsatisfied) to 7 (very satisfied) | Immediately Post-Intervention and 3 Months Post-Intervention |
| New medications or changes in their anti-hypertensive medication use | 3 Months Post-Intervention |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
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