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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of Primary Care Follow Up
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be 45 years of age or older
- •Must have high blood pressure, diabetes mellitus, or obesity (body mass index ≥30 kg/m2)
排除标准
- •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
研究组 & 干预措施
Educational Intervention Alone
干预措施: Educational Intervention Alone (Other)
Ultrasound and Educational Intervention
干预措施: Ultrasound and Educational Intervention (Other)
结局指标
主要结局
Rate of Primary Care Follow Up
时间窗: 3 Months Post-Intervention
Defined as the presence or absence of a follow up visit with a primary care provider at 3 months
次要结局
- Likelihood to Follow Up with a Primary Care Physician within the 3 Months Post-Intervention(Baseline and Immediately Post-Intervention)
- Self-perceived knowledge of heart failure(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(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(Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention)
- Likelihood to change their fat intake using the Stages of Change for Dietary Fat tool(Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention)
- Likelihood to change their exercise using the Stages of Change for Physical Activity(Baseline, Immediately Post-Intervention, and 3 Months Post-Intervention)
- Change in diet quality using the Mediterranean Eating Pattern for Americans tool(Baseline and 3 Months Post-Intervention)
- Change in exercise status using the Exercise Vital Sign tool(Baseline and 3 Months Post-Intervention)
- Satisfaction with the educational intervention(Immediately Post-Intervention and 3 Months Post-Intervention)
- New medications or changes in their anti-hypertensive medication use(3 Months Post-Intervention)
研究者
Michael Gottlieb
Professor of Emergency Medicine, Vice Chair of Research
Rush University Medical Center