E3 Hypertension - A Team-based, Multidisciplinary Model in Addressing Barriers to Hypertension Control

NCT06899750 | Recruiting

• 1 other identifier: 24100803
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

hypertension; self-monitoring; social determinants of health; adherence

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure change at 6 months

  Percentage of participants with a decrease in systolic blood pressure of at least 10mmHg between pre and post clinic-based blood pressure measurements.

  6 months

Secondary Outcomes (1)

• Hypertension control at 9 months

  9 months

Study Arms (2)

Hypertension Team Based Group

EXPERIMENTAL

A multidisciplinary team composed of a pharmacist, social worker, and nurse coupled to a self-monitoring blood pressure phone app will provide hypertension monitoring, medication titration, diet and lifestyle education, and referrals for social needs. The team will interact with the patients predominantly via tele-health remotely for 6 months.

Behavioral: E3 Multidisciplinary Team

Hypertension Self-Guided Group

ACTIVE COMPARATOR

A research assistant ensures patients in the self-guided group have a home blood pressure monitor on enrollment and will call patients at 3 and 6 months to ensure the blood pressure monitor is functioning correctly and to remind patients to check their blood pressure and follow-up with their primary care doctors. Patients will continue with standard clinical care for hypertension in addition to receiving timed, mailed educational materials on hypertension, remote monitoring, diet and lifestyle recommendations for 6 months.

Behavioral: E3 Self-Guided Hypertension Education Program

Interventions

E3 Multidisciplinary Team BEHAVIORAL

The E3 Multidisciplinary team is composed of a remote pharmacist, social worker, and nurse working together with patients via a remote monitoring, educational hypertension phone app to overcome barriers to hypertension control via behavioral change, medication adherence and titration, diet and lifestyle education and resource referrals for social needs.

Hypertension Team Based Group

E3 Self-Guided Hypertension Education Program BEHAVIORAL

Patients will receive timed, mailed educational materials on hypertension self-monitoring, diet and lifestyle modifications to supplement usual clinic-based hypertension care with their primary care doctor. A research assistant will ensure patients have home blood pressure monitors on enrollment, and will remind patients to check their blood pressures and follow-up with their primary care doctors at 3 months and 6 months.

Hypertension Self-Guided Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kristen Pallok, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen Pallok, MD

CONTACT

13129426700; Kristen_N_Pallok@rush.edu

Elizabeth Legorreta, MSN, NP-C

CONTACT

3129426700; Elizabeth_M_Legorreta@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 28, 2025
• Study Start: February 10, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)