Clinical trial NCT06899750: E3 Hypertension - A Team-based, Multidisciplinary Model in Addressing Barriers to Hypertension Control
Official title: E3 Hypertension - A Team-based, Multidisciplinary Model in Addressing Barriers to Hypertension Control
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: hypertension
self-monitoring
social determinants of health
adherence
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2025-03-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare a multidisciplinary clinical hypertension and social needs intervention to enhanced standard of care for hypertension management in primary care clinics with regards to hypertension control outcomes.

Detailed description: Cardiovascular disease (CVD) is the leading cause of death in the US as well as in Chicago. Risk factors for CVD include hypertension, diabetes, and lifestyle factors such as smoking, diet, and obesity. Among the critical social and structural determinants of cardiovascular health are food access, neighborhood safety, education, poverty, and chronic stress. Chicago and its surrounding region suffer from longstanding racial disparities in both social conditions and chronic disease burden, contributing to stark racial gaps in cardiometabolic disease mortality. Life expectancy is as high as 84 years on Chicago's North Side, but only 68 years on the West Side - a gap of 16 years.

Rush has collaborated with Novartis to "close the gap" in CVD inequities on Chicago's West Side by concentrating a critical mass of resources on community-centric approaches to wellness, prevention and management. Engage, Empower, Evaluate (E3) has been built on the foundation of Rush's mission to ensure that all patients and individuals at risk of developing CVD on Chicago's West Side receive the care they need, regardless of race/ethnicity, socioeconomic status, gender, or neighborhood, with the ultimate goal to reduce the CVD life expectancy gap for West Side residents by 50% by 2030. To do so, the study team coordinated clinical and community programming into a seamless health-promoting environment, tailored to the specific needs of the population, through remote monitoring and a multidisciplinary team composed of a nurse, social worker, and pharmacist.

The study team now proposes a trial of the E3 intervention, a remote hypertension monitoring, social care, medication adherence and behavioral lifestyle intervention to improve hypertension control among African American and Latinx patients attending primary care clinics at Rush University Medical Group locations with the eventual aim of closing the racial/ethnic disparity in hypertension control. The proposed feasibility trial will use a randomized-control, four-pronged approach to improve hypertension control. The intervention group will receive the following: 1) remote blood pressure monitoring, 2) a multidisciplinary team composed of nurse, pharmacist and social worker to address medical and social needs, 3) medication titration and adherence support, and 4) a culturally tailored hypertension self-management and diet education mobile phone application. The control group will receive an enhanced version of standard of care for hypertension through a home blood pressure cuff, and dietary and lifestyle educational materials tailored to hypertension self-management sent at timed intervals. The study team hypothesizes that the E3 Hypertension program participants will achieve a greater decrease in systolic blood pressure, and a greater percentage will have reduction of blood pressure below stage 2 hypertension (\<140/90) in comparison to the control group receiving enhanced standard of care for hypertension.

Eligibility criteria: Inclusion Criteria:

* Adults 18 years or older
* African American and/or Latinx
* Uncontrolled stage 2 hypertension, BP \>/= 140/90
* Patient is following with Rush primary care provider in eligible Rush primary care clinics
* Patient has a smart phone (Android or iOS)
* Patient has an email

Exclusion Criteria:

* Organ transplant recipient
* On dialysis
* Patient is already participating in another remote hypertension monitoring program
* Patient is not interested in participating in the program
* Patient has already participated in the E3 Hypertension program or the E3 Diabetes program

Primary outcomes:
measure: Systolic blood pressure change at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Hypertension control at 9 months
timeFrame: 9 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Kristen Pallok, MD
role: PRINCIPAL_INVESTIGATOR
References: