Recruiting

Hypertension Management

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06527794

Conditions

Uncontrolled Hypertension

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

RHYTHM (Remote Hypertension Tracking Help Management)

Enhanced usual care (UC)

Study Details

Brief summary:

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.

Conditions

Uncontrolled Hypertension

Study ID

NCT06527794

Start date

Dec 13, 2024

Status verified date

May, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

864 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: RHYTHM (Remote Hypertension Tracking Help Management)

home blood pressure telemonitoring with remote medication management and social support, lifestyle education and connection to community resources to address social needs

experimental: Enhanced usual care (UC)

standardized packet with evidence-based hypertension education material and a blood pressure monitor to complete blood pressure measurements at home

Interventions

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

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 outcome measure

  • Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 12 [ Time Frame: Month 12 ]

Central Contacts and Locations

Central contacts

Yhenneko J. Taylor, PhD

(704) 355-6562Yhenneko.Taylor@advocatehealth.org

Asha Ganesan

asha.ganesan@advocatehealth.org

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Yhenneko Taylor, PhD

704-355-6562Yhenneko.Taylor@atriumhealth.org

Asha Ganesan

asha.ganesan@advocatehealth.org

Principal Investigator:

Yhenneko Taylor, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • high blood pressure
  • African-American population
  • remote blood pressure monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-06-02.