Remote Monitoring and Social Intervention for High Blood Pressure
(E3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach to help African American and Latinx individuals manage high blood pressure. It combines remote blood pressure monitoring with support from a team of health professionals, including a community health worker, pharmacist, nurse, and social worker. The goal is to reduce racial disparities in high blood pressure management. Suitable participants have high blood pressure of 140/90 or greater, are African American or Latinx, and can use a phone or device with video capabilities at home. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for managing high blood pressure in diverse communities.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this remote monitoring and social intervention is safe for high blood pressure patients?
In a previous study, researchers found that checking blood pressure from home with added social support did not improve blood pressure control compared to regular care. However, another study showed that remote methods might be more effective at lowering blood pressure due to their timeliness and consistency.
In this trial, researchers will monitor participants' blood pressure from home and provide social support. This approach has been used before and is considered safe. The studies did not report any major safety issues, indicating that this treatment is generally well-tolerated. Participants did not experience serious side effects, suggesting that the treatment should be safe for most people.12345Why are researchers excited about this trial?
Researchers are excited about the Remote Monitoring and Social Intervention treatment for high blood pressure because it uses a novel approach combining technology and community support. Unlike traditional treatments that primarily rely on medication, this method involves remote blood pressure monitoring alongside personalized outreach from a team of healthcare professionals, including community health workers, pharmacists, nurses, and social workers. This comprehensive approach aims to address not just the physical aspects of high blood pressure, but also the social factors that can impact health, potentially leading to more sustainable blood pressure control.
What evidence suggests that this remote monitoring and social intervention is effective for high blood pressure?
Studies have shown that remote monitoring combined with social support can significantly aid in controlling blood pressure. This trial will enroll participants in a remote blood pressure monitoring program and social intervention. One study found that systolic blood pressure improved by 7.3 mmHg overall and by 16.7 mmHg for individuals with more severe hypertension. Another report highlighted that remote methods outperform other approaches by providing timely and ongoing support. This method addresses gaps in care and can be particularly effective in reducing racial disparities in managing high blood pressure.35678
Who Is on the Research Team?
David A Ansell, MD, MPH
Principal Investigator
Rush University Medical Center
Laura J Zimmermann, MD
Principal Investigator
Rush University Medical Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
Follow-up
Participants are monitored for sustained improvement in blood pressure and adherence to interventions, with follow-up assessments at 3-6 months.
What Are the Treatments Tested in This Trial?
Interventions
- E3 Remote Monitoring and Social Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rush University Medical Center
Lead Sponsor
Novartis Pharmaceuticals
Industry Sponsor
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