Novartis - Closing the Gap in Cardiovascular Risk: Engage, Empower, Evaluate

NCT06027905 | Completed

• 2 other identifiers: 221230021036009
• Study Type: interventional
• Target: 445
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 improvement from stage II hypertension (140/90 mmHg or above) to blood pressure below 130/80 mmHg with home cuff through self monitoring

  Baseline, 12 weeks

• Percentage of total participants with sustained improvement of blood pressure below 130/80 mmHg at 3-6 month follow-up

  Percentage of total participants with sustained improvement of blood pressure below 130/80 mmHg after the intervention at 3-6 month clinic follow-up as measured with a clinic measured blood pressure

  3-6 month follow-up after the 12 week intervention

Secondary Outcomes (3)

• Correlation of change in SDOH survey score in relation to hypertension control below 130/80 mmHg

  Baseline, 12 weeks

• Correlation of initial SDOH survey score in relation to hypertension control below 130/80 mmHg

  Baseline, 12 weeks

• Correlation of frequency of self monitoring with post intervention ARMS survey scores

  Baseline, 12 weeks

Study Arms (1)

Remote Blood Pressure Monitoring and Social Intervention

EXPERIMENTAL

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.

Other: E3 Remote Monitoring and Social Intervention

Interventions

E3 Remote Monitoring and Social Intervention OTHER

Patients are enrolled in a 12 week remote blood pressure monitoring program composed of a community health worker, nurse, pharmacist and social worker. Participants will receive a home cellular blood pressure cuff for remote monitoring and will receive tele-health calls from their community health worker to assist with blood pressure taking technique and adherence, medication adherence, education around diet and activity. Social work is available to provide institutional and community resources to patients with social needs. Patients will be screened pre intervention and post intervention for medication adherence and social determinants of health needs. The team nurse monitors and triages home blood pressures on the remote portal. The pharmacist assists with medication reconciliation, adherence, and titration of medications according to standards or care.

Remote Blood Pressure Monitoring and Social Intervention

Eligibility Criteria

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

You may qualify if:

• African American and/or Latinx self-identifying
• Stage II hypertension (140/90) or greater
• Following with Rush primary care provider in eligible Rush primary care clinic
• Access to phone or device with video capabilities in the home

You may not qualify if:

• Dialysis patient
• Organ transplant recipient

Sponsors & Collaborators

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

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Social Work

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Officials

• David A Ansell, MD, MPH

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Laura J Zimmermann, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 7, 2023
• Study Start: September 13, 2023
• Primary Completion: November 1, 2024
• Study Completion: May 12, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (1)