Use of Bedside Imaging and Community Health Workers for Early Screening and Referral of Pre-symptomatic Stage B Heart Failure in the Emergency Department

NCT06769880 | Recruiting

• 2 other identifiers: 23112905P50MD017349
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.Does POCUS increase understanding of heart failure and the likelihood to improve diet, exercise, and follow up?
2. 2.Does POCUS improve diet, exercise, follow up, and self-efficacy at three months post-intervention?

Conditions

Heart Diseases

Keywords

POCUS; Ultrasound; Ultrasonography; Echocardiography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Likelihood to Follow Up with a Primary Care Physician within the 3 Months Post-Intervention

  Baseline and Immediately Post-Intervention

• Self-perceived knowledge of heart failure

  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

Study Arms (2)

Educational Intervention Alone

PLACEBO COMPARATOR

Other: Educational Intervention Alone

Ultrasound and Educational Intervention

EXPERIMENTAL

Other: Ultrasound and Educational Intervention

Interventions

Ultrasound and Educational Intervention OTHER

This will include the educational intervention combined with a point-of-care ultrasound

Ultrasound and Educational Intervention

Educational Intervention Alone OTHER

This will include only the educational intervention (without ultrasound)

Educational Intervention Alone

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 45 years of age or older
• Must have high blood pressure, diabetes mellitus, or obesity (body mass index ≥30 kg/m2)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Michael Gottlieb, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aylin Ornelas Loredo, MMS

CONTACT

312-563-0645; aylin_a_ornelasloredo@rush.edu

Michelle Santangelo, MS

CONTACT

312-563-0645; michelle_santangelo@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Emergency Medicine, Vice Chair of Research

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)