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

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Status

Enrolling

Conditions

Heart Diseases

Treatments

Other: Ultrasound and Educational Intervention
Other: Educational Intervention Alone

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06769880
P50MD017349 (U.S. NIH Grant/Contract)
23112905

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups, including a placebo group

Educational Intervention Alone
Placebo Comparator group
Treatment:
Other: Educational Intervention Alone
Ultrasound and Educational Intervention
Experimental group
Treatment:
Other: Ultrasound and Educational Intervention

Trial contacts and locations

1

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Central trial contact

Michelle Santangelo, MS; Aylin Ornelas Loredo, MMS

Data sourced from clinicaltrials.gov

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