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NCT Number: 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

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.

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Key information

Conditions

Heart Diseases Cardiovascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound and Educational Intervention

Other

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

Educational Intervention Alone

Other

This will include only the educational intervention (without ultrasound)

Primary outcomes

  1. Rate of Primary Care Follow Up

    Time frame: 3 Months Post-Intervention

    Defined as the presence or absence of a follow up visit with a primary care provider at 3 months

Secondary outcomes

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

    Time frame: Baseline and Immediately Post-Intervention

    Ordinal scale of 1 (very unlikely) to 7 (very likely)

  2. Self-perceived knowledge of heart failure

    Time frame: Baseline and Immediately Post-Intervention

    Ordinal scale of 1 (no knowledge) to 7 (extremely knowledgeable)

  3. Degree of motivation and self-efficacy using a modified High Blood Pressure Self-Care Profile (HBP-SCP) Motivation and Self-Efficacy tool

    Time frame: Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention

  4. Likelihood to change their fruit and vegetable intake using the Stages of Change tools for Fruits and Vegetables

    Time frame: Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention

  5. Likelihood to change their fat intake using the Stages of Change for Dietary Fat tool

    Time frame: Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention

  6. Likelihood to change their exercise using the Stages of Change for Physical Activity

    Time frame: Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention

  7. Change in diet quality using the Mediterranean Eating Pattern for Americans tool

    Time frame: Baseline and 3 Months Post-Intervention

  8. Change in exercise status using the Exercise Vital Sign tool

    Time frame: Baseline and 3 Months Post-Intervention

  9. Satisfaction with the educational intervention

    Time frame: Immediately Post-Intervention and 3 Months Post-Intervention

    Ordinal scale of 1 (very unsatisfied) to 7 (very satisfied)

  10. New medications or changes in their anti-hypertensive medication use

    Time frame: 3 Months Post-Intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Aylin Ornelas Loredo, MMS

CONTACT

[email protected]

312-563-0645

Michelle Santangelo, MS

CONTACT

[email protected]

312-563-0645

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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