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

Not Applicable

Not yet recruiting

• Conditions: Heart Diseases

• Registration Number: NCT06769880
• Lead Sponsor: Rush University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Study Start: 2025-07
• Primary Completion: 2026-06
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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 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	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

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States