Recruiting
Remote Hypertension Management for Black Patients
This study will compare two approaches for managing hypertension in Black patients with uncontrolled blood pressure (BP). One approach will include home BP telemonitoring supported by a pharmacist and a community health worker. The other approach will include usual clinic-based care along with a home BP monitor and routine care.
ClinicalTrials.gov IDNCT06527794
PhaseNA
Enrollment864
SponsorWake Forest University Health Sciences
Age21 Years
SexALL
Conditions studied
Uncontrolled Hypertension
About this study
This study will compare two approaches for managing hypertension in Black patients with uncontrolled blood pressure (BP). One approach will include home BP telemonitoring supported by a pharmacist and a community health worker. The other approach will include usual clinic-based care along with a home BP monitor and routine care.
Interventions
- Behavioral: RHYTHM (Remote Hypertension Tracking Help Management) — Home blood pressure telemonitoring with remote medication management by a centralized multidisciplinary team led by a pharmacist; and social support, lifestyle education and connection to community resources to address social needs, provided by a community health worker who is embedded with the centralized team and is tightly connected to community resources and partners
- Behavioral: Enhanced usual care (UC) — All participating sites will receive training on appropriate blood pressure measurement and education on guideline-based hypertension therapy. Additionally, participants in usual care will receive a standardized packet with evidence-based hypertension education material and a blood pressure monitor to complete blood pressure measurements at home.
Primary outcomes
- Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 12 (Month 12)
Eligibility information
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.
Study locations
- Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.