Remote Hypertension Management for Black Patients (RHYTHM-B)

Wake Forest University (WFU)

Status: Enrolling

Conditions: Uncontrolled Hypertension

Treatments: Behavioral: Enhanced usual care (UC); Behavioral: RHYTHM (Remote Hypertension Tracking Help Management)

Study type: Interventional

Funder types: Other

Identifiers

NCT06527794

IRB00112245

BPS-2023C1-31377 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

This study is a pragmatic effectiveness-implementation hybrid type 2 trial with two study arms. One arm will include home BP telemonitoring supported by a pharmacist and a community health worker providing centralized self-management support. The other arm will include enhanced usual clinic-based care with a home BP monitor and routine care from providers trained on evidence-based guidelines.

Enrollment: 864 estimated patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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864 participants in 2 patient groups

RHYTHM (Remote Hypertension Tracking Help Management)

Experimental group

Description:

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

Treatment:

Behavioral: RHYTHM (Remote Hypertension Tracking Help Management)

Enhanced usual care (UC)

Experimental group

Description:

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

Treatment:

Behavioral: Enhanced usual care (UC)