Use of Bedside Imaging and Community Health Workers for Early Screening and Referral of Pre-symptomatic Stage B Heart Failure in the Emergency Department
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound and Educational Intervention, Educational Intervention Alone.
- Who it may be relevant to
- Registry conditions: Heart Diseases. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other Ultrasound and Educational Intervention
This will include the educational intervention combined with a point-of-care ultrasound - Other Educational Intervention Alone
This will include only the educational intervention (without ultrasound)
Primary outcome measures
- Rate of Primary Care Follow Up [Time frame: 3 Months Post-Intervention]
Secondary outcome measures (10)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Rush University Medical Center — Chicago
Identifiers
NCT: NCT06769880 · 23112905 · P50MD017349