Remote Hypertension Management for Black Patients

NCT06527794 | Recruiting DMC

• 2 other identifiers: IRB00112245BPS-2023C1-31377
• Study Type: interventional
• Target: 864
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Percent of patients achieving BP control (i.e., SBP\<130mmHg)

  Month 12

Secondary Outcomes (18)

• Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Baseline

  Baseline

• Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 6

  Month 6

• Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 18

  Month 18

• Systolic blood pressure (mmHg) - Baseline

  Baseline

• Systolic blood pressure (mmHg) - Month 6

  Month 6

Other Outcomes (1)

• Therapeutic intensification Score

  Month 12

Study Arms (2)

RHYTHM (Remote Hypertension Tracking Help Management)

EXPERIMENTAL

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

Behavioral: RHYTHM (Remote Hypertension Tracking Help Management)

Enhanced usual care (UC)

EXPERIMENTAL

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

Behavioral: Enhanced usual care (UC)

Interventions

RHYTHM (Remote Hypertension Tracking Help Management) BEHAVIORAL

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

RHYTHM (Remote Hypertension Tracking Help Management)

Enhanced usual care (UC) BEHAVIORAL

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.

Enhanced usual care (UC)

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yhenneko J. Taylor, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yhenneko J. Taylor, PhD

CONTACT

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

Asha Ganesan

CONTACT

asha.ganesan@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: December 13, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The Policy calls for maintenance of the Full Data Package for seven (7) years following acceptance by PCORI of the Final Research Report. In that time, PCORI may provide funds for the deposition of the Full Data Package to the PCORI-designated repository in circumstances where PCORI requests such deposition (e.g., due to PCORI estimate of high importance of research project findings or external research request).
• Access Criteria: Individual investigators or teams of investigators seeking access to data from PCORI-funded studies must complete and submit a data request form to the PCORI-designated repository. There are no categorical restrictions on what types of individuals or entities may request to access the PCORI Awardee research data. Data requestors will be evaluated for their overall qualifications and experience (e.g., across a proposed team of specified individuals) to achieve the stated research purpose underlying the data request.

Locations

US (1)