Heart Diseases
Conditions
Keywords
POCUS, Ultrasound, Ultrasonography, Echocardiography
Brief summary
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: 1. Does POCUS increase understanding of heart failure and the likelihood to improve diet, exercise, and follow up? 2. Does POCUS improve diet, exercise, follow up, and self-efficacy at three months post-intervention? 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.
Interventions
OTHERUltrasound and Educational Intervention
This will include the educational intervention combined with a point-of-care ultrasound
OTHEREducational Intervention Alone
This will include only the educational intervention (without ultrasound)
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Must be 45 years of age or older * Must have high blood pressure, diabetes mellitus, or obesity (body mass index ≥30 kg/m2)
Exclusion criteria
* Symptoms of acute heart failure (difficulty breathing, leg swelling) * History of heart failure * Unable to tolerate an ultrasound examination * No access to a phone for follow up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Primary Care Follow Up | 3 Months Post-Intervention | Defined as the presence or absence of a follow up visit with a primary care provider at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-perceived knowledge of heart failure | Baseline and Immediately Post-Intervention | Ordinal scale of 1 (no knowledge) to 7 (extremely knowledgeable) |
| 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 Follow Up with a Primary Care Physician within the 3 Months Post-Intervention | Baseline and Immediately Post-Intervention | Ordinal scale of 1 (very unlikely) to 7 (very likely) |
| 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 | Immediately Post-Intervention and 3 Months Post-Intervention | Ordinal scale of 1 (very unsatisfied) to 7 (very satisfied) |
| New medications or changes in their anti-hypertensive medication use | 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 | — |
Countries
United States
Contacts
Primary ContactAylin Ornelas Loredo, MMS
Backup ContactMichelle Santangelo, MS
Outcome results
None listed