Remote Monitoring and Social Intervention for High Blood Pressure

(E3 Trial)

Overseen By Elizabeth Legorreta, MSN, NP-C

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Dialysis, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

1200 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to decrease the racial gap in high blood pressure in African American and Latinx patients in Rush University Medical Center clinics.

Research Team

David A Ansell, MD, MPH

Principal Investigator

Rush University Medical Center

Laura J Zimmermann, MD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

This trial is for African American and Latinx individuals with Stage II high blood pressure (140/90 or higher) who are patients at eligible Rush University Medical Center clinics. Participants must have access to a phone or device with video capabilities.

Inclusion Criteria

My blood pressure is 140/90 or higher.

Following with Rush primary care provider in eligible Rush primary care clinic

Access to phone or device with video capabilities in the home

Exclusion Criteria

I have received an organ transplant.

I am on dialysis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Enrollment and Initial Intervention

Participants are enrolled and introduced to the program, including verbal consent and initial screenings for social determinants of health and medication adherence.

1 week

1 visit (in-person or virtual)

Remote Monitoring and Intervention

Participants engage in remote blood pressure monitoring and receive weekly virtual visits from community health workers, with additional interventions from nurses and pharmacists as needed.

12 weeks

Weekly virtual visits

Follow-up

Participants are monitored for sustained improvement in blood pressure and adherence to interventions, with follow-up assessments at 3-6 months.

3-6 months

1-2 visits (virtual)

Treatment Details

Interventions

• E3 Remote Monitoring and Social Intervention

Trial Overview The study tests the 'E3 Remote Monitoring and Social Intervention' program, aiming to reduce racial disparities in managing high blood pressure among African American and Latinx communities.

Participant Groups

Group I: Remote Blood Pressure Monitoring and Social Intervention Experimental Treatment 1 Intervention

Participants are enrolled in a remote blood pressure monitoring program and social intervention composed of remote outreach from a team of community health worker, pharmacist, nurse, and social worker for 12 weeks.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Novartis Pharmaceuticals

Industry Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD