Clinical trial NCT06769880: Use of Bedside Imaging and Community Health Workers for Early Screening and Referral of Pre-symptomatic Stage B Heart Failure in the Emergency Department
Official title: Combating Health Disparities Using Bedside Imaging and Community Health Workers for Early Screening and Referral of Pre-symptomatic Stage B Heart Failure in the Emergency Department
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Diseases
Keywords: POCUS
Ultrasound
Ultrasonography
Echocardiography
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Primary Care Follow Up
timeFrame: 3 Months Post-Intervention
Secondary outcomes:
measure: Likelihood to Follow Up with a Primary Care Physician within the 3 Months Post-Intervention
timeFrame: Baseline and Immediately Post-Intervention
measure: Self-perceived knowledge of heart failure
timeFrame: Baseline and Immediately Post-Intervention
measure: Degree of motivation and self-efficacy using a modified High Blood Pressure Self-Care Profile (HBP-SCP) Motivation and Self-Efficacy tool
timeFrame: Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention
measure: Likelihood to change their fruit and vegetable intake using the Stages of Change tools for Fruits and Vegetables
timeFrame: Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention
measure: Likelihood to change their fat intake using the Stages of Change for Dietary Fat tool
timeFrame: Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention
measure: Likelihood to change their exercise using the Stages of Change for Physical Activity
timeFrame: Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention
measure: Change in diet quality using the Mediterranean Eating Pattern for Americans tool
timeFrame: Baseline and 3 Months Post-Intervention
measure: Change in exercise status using the Exercise Vital Sign tool
timeFrame: Baseline and 3 Months Post-Intervention
measure: Satisfaction with the educational intervention
timeFrame: Immediately Post-Intervention and 3 Months Post-Intervention
measure: New medications or changes in their anti-hypertensive medication use
timeFrame: 3 Months Post-Intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Michael Gottlieb, MD
role: PRINCIPAL_INVESTIGATOR
References: