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

NCT ID: NCT06769880

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-13

Study Completion Date

2026-09-30

Brief Summary

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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:

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

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Conditions

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Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Educational Intervention Alone

Group Type PLACEBO_COMPARATOR

Educational Intervention Alone

Intervention Type OTHER

This will include only the educational intervention (without ultrasound)

Ultrasound and Educational Intervention

Group Type EXPERIMENTAL

Ultrasound and Educational Intervention

Intervention Type OTHER

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

Interventions

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Ultrasound and Educational Intervention

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

Intervention Type OTHER

Educational Intervention Alone

This will include only the educational intervention (without ultrasound)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Michael Gottlieb

Professor of Emergency Medicine, Vice Chair of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Gottlieb, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Aylin Ornelas Loredo, MMS

Role: CONTACT

312-563-0645

Michelle Santangelo, MS

Role: CONTACT

312-563-0645

Facility Contacts

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Aylin Ornelas Loredo, MMS

Role: primary

312-563-0645

Michelle Santangelo, MS

Role: backup

312-563-0645

Other Identifiers

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P50MD017349

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23112905

Identifier Type: -

Identifier Source: org_study_id

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