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Remote Monitoring and Social Intervention for High Blood Pressure (E3 Trial)
N/A
Waitlist Available
Led By David A Ansell, MD, MPH
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stage II hypertension (140/90) or greater
Be older than 18 years old
Must not have
Organ transplant recipient
Dialysis patient
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 month follow-up after the 12 week intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial seeks to reduce unequal high BP rates between African American & Latinx patients in Rush University Medical Center clinics.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves remote monitoring and social interventions rather than medication, traditional side effects are not applicable. However, participants may experience privacy concerns or stress related to constant health monitoring.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood pressure is 140/90 or higher.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have received an organ transplant.
Select...
I am on dialysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-6 month follow-up after the 12 week intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 month follow-up after the 12 week intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of total participants with improvement of hypertension to below 130/80 mmHg and/or a decrease of 10mmHg in systolic readings
Percentage of total participants with sustained improvement of blood pressure below 130/80 mmHg at 3-6 month follow-up
Secondary study objectives
Correlation of change in SDOH survey score in relation to hypertension control below 130/80 mmHg
Correlation of frequency of self monitoring with post intervention ARMS survey scores
Correlation of initial SDOH survey score in relation to hypertension control below 130/80 mmHg
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Remote Blood Pressure Monitoring and Social InterventionExperimental Treatment1 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.
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Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
436 Previous Clinical Trials
248,052 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,916 Previous Clinical Trials
4,252,685 Total Patients Enrolled
David A Ansell, MD, MPHPrincipal InvestigatorRush University Medical Center
Laura J Zimmermann, MDPrincipal InvestigatorRush University Medical Center