Managing high blood pressure in Black patients remotely

Remote Hypertension Tracking, Help, and Management to Reduce Disparities in Black Patients

This study tests whether managing high blood pressure at home with help from a pharmacist and a community health worker works better than regular clinic care for Black patients with uncontrolled hypertension.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 864 (estimated)
• Ages: 21 Years to 85 Years
• Sex: All
• Sponsor: Wake Forest University Health Sciences (Academic / other)
• Locations: 1 site (Winston-Salem, North Carolina)
• Trial ID: NCT06527794 on ClinicalTrials.gov

What this trial studies

This study compares two methods for managing uncontrolled hypertension in Black patients. One method involves home blood pressure telemonitoring with support from a pharmacist and a community health worker, while the other method provides enhanced usual clinic-based care along with a home blood pressure monitor. The trial aims to evaluate the effectiveness of these approaches in improving blood pressure control. It is designed as a pragmatic effectiveness-implementation hybrid trial with two distinct study arms.

Who should consider this trial

Good fit: Ideal candidates are Black or African American adults aged 21 to 85 with uncontrolled hypertension.

Not a fit: Patients who are currently pregnant or planning to become pregnant during the study period may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved blood pressure management and health outcomes for Black patients with hypertension.

How similar studies have performed: Other studies have shown success with remote monitoring approaches for hypertension management, indicating potential for positive outcomes in this population.

Eligibility criteria

Inclusion Criteria:

* Black or African American race
* Hypertension diagnosis
* aged 21 to 85 years
* Uncontrolled blood pressure as defined by \[a\] most recent SBP ≥140 mmHg and an additional SBP≥140 mmHg within the past 12 months in an outpatient setting (excluding urgent care, emergency department or surgery clinic), or \[b\] most recent SBP\>160mmHg in an outpatient setting (excluding urgent care, emergency department or surgery clinic), or \[c\] referral by PCP for uncontrolled hypertension with at least one documented SBP≥140 mmHg (in clinic or at home) in the past 12 months; and (v) primary care provided at a participating clinic.
* Able to speak English
* Primary care provided at a participating clinic

Exclusion Criteria:

* currently pregnant or planning to get pregnant during the study period
* residence in a long-term care facility, hospice or with a terminal illness with less than 1 year life expectancy as determined by the Primary Care Physician or study team. Stable chronic illness such as compensated cirrhosis, chronic obstructive pulmonary disease, congestive heart failure etc. will not be excluded.
* estimated Glomerular Filtration Rate (eGFR) \<30 ml/min or on dialysis. Patients with a functioning kidney transplant will not be excluded.
* inability to provide informed consent or participate in study procedures. For example, conditions that limit ability to participate in phone visits or check BPs in at least one arm.
* currently participating in another BP management program.
* plan to move out of the area within the next 12 months.
* Hispanic ethnicity.

Where this trial is running

Winston-Salem, North Carolina

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Yhenneko J. Taylor, PhD — Wake Forest University Health Sciences
• Study coordinator: Yhenneko J. Taylor, PhD

Conditions Uncontrolled Hypertension; high blood pressure; African-American population; remote blood pressure monitoring