Heart DiseasesNCT06769880
Use of Bedside Imaging and Community Health Workers for Early Screening and Referral of Pre-symptomatic Stage B Heart Failure in the Emergency Department
A study testing Ultrasound and Educational Intervention and Educational Intervention Alone in people with Heart Diseases, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Ultrasound and Educational Intervention and Educational Intervention Alone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be 45 years of age or older
- Must have high blood pressure, diabetes mellitus, or obesity (body mass index ≥30 kg/m2)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official 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
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:
- Does POCUS increase understanding of heart failure and the likelihood to improve diet, exercise, and follow up?
- Does POCUS improve diet, exercise, follow up, and self-efficacy at three months post-intervention?
Read more
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.
- Conditions
- Heart Diseases
- Being tested
- Ultrasound and Educational Intervention, Educational Intervention Alone
- Keywords
- POCUS, Ultrasound, Ultrasonography, Echocardiography
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound and Educational InterventionOther
This will include the educational intervention combined with a point-of-care ultrasound
Educational Intervention AloneOther
This will include only the educational intervention (without ultrasound)
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention Alone | Placebo comparator | Not described Receives: Other: Educational Intervention Alone |
| Ultrasound and Educational Intervention | Experimental | Not described Receives: Other: Ultrasound and Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 Months Post-Intervention
Secondary outcomes (10)
Likelihood to Follow Up with a Primary Care Physician within the 3 Months Post-Intervention
Ordinal scale of 1 (very unlikely) to 7 (very likely)
Measured: Baseline and Immediately Post-Intervention
Self-perceived knowledge of heart failure
Ordinal scale of 1 (no knowledge) to 7 (extremely knowledgeable)
Measured: 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
Measured: 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
Measured: Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention
Likelihood to change their fat intake using the Stages of Change for Dietary Fat tool
Measured: Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention
Likelihood to change their exercise using the Stages of Change for Physical Activity
Measured: Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention
Change in diet quality using the Mediterranean Eating Pattern for Americans tool
Measured: Baseline and 3 Months Post-Intervention
Change in exercise status using the Exercise Vital Sign tool
Measured: Baseline and 3 Months Post-Intervention
Satisfaction with the educational intervention
Ordinal scale of 1 (very unsatisfied) to 7 (very satisfied)
Measured: Immediately Post-Intervention and 3 Months Post-Intervention
New medications or changes in their anti-hypertensive medication use
Measured: 3 Months Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start13 Oct 2025
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Michael Gottlieb, Rush University Medical Center
- Investigators
- Michael Gottlieb, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769880
- Sponsor's protocol ID
- 23112905
- Other IDs
- P50MD017349
- Status last verified
- Sep 2025
- First submitted
- 6 Jan 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06769880
- Acronym / sponsor ID
- 23112905
- Conditions
- Heart Diseases
- Keywords
- POCUS, Ultrasound, Ultrasonography, Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does POCUS increase understanding of heart failure and the likelihood to improve diet, exercise, and follow up?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention Alone | Placebo comparator | Other: Educational Intervention Alone |
| Ultrasound and Educational Intervention | Experimental | Other: Ultrasound and Educational Intervention |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be 45 years of age or older
- Must have high blood pressure, diabetes mellitus, or obesity (body mass index ≥30 kg/m2)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound and Educational InterventionThis will include the educational intervention combined with a point-of-care ultrasound | Other | Ultrasound and Educational Intervention |
| Educational Intervention AloneThis will include only the educational intervention (without ultrasound) | Other | Educational Intervention Alone |
Primary outcome
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
10 secondary outcomes
Likelihood to Follow Up with a Primary Care Physician within the 3 Months Post-Intervention
Time frame: Baseline and Immediately Post-Intervention
Self-perceived knowledge of heart failure
Time frame: 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
Time frame: 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
Time frame: Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention
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
Likelihood to change their exercise using the Stages of Change for Physical Activity
Time frame: Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention
Change in diet quality using the Mediterranean Eating Pattern for Americans tool
Time frame: Baseline and 3 Months Post-Intervention
Change in exercise status using the Exercise Vital Sign tool
Time frame: Baseline and 3 Months Post-Intervention
Satisfaction with the educational intervention
Time frame: Immediately Post-Intervention and 3 Months Post-Intervention
New medications or changes in their anti-hypertensive medication use
Time frame: 3 Months Post-Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Gottlieb, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and Educational Intervention and Educational Intervention Alone in people with Heart Diseases, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Primary Care Follow Up (time frame: 3 Months Post-Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.