Remote Hypertension Management for Black Patients (RHYTHM-B)

Remote Hypertension Tracking, Help, and Management to Reduce Disparities in 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.

Study Overview

• Status: Recruiting
• Conditions: Uncontrolled Hypertension
• Intervention / Treatment: Behavioral: RHYTHM (Remote Hypertension Tracking Help Management); Behavioral: Enhanced usual care (UC)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 864
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yhenneko J. Taylor, PhD; Phone Number: (704) 355-6562; Email: Yhenneko.Taylor@advocatehealth.org
• Study Contact Backup: Name: Asha Ganesan; Email: asha.ganesan@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Yhenneko Taylor, PhD; Phone Number: 704-355-6562; Email: Yhenneko.Taylor@atriumhealth.org
      • Principal Investigator: Yhenneko Taylor, PhD
      • Contact: Asha Ganesan; Email: asha.ganesan@advocatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 6	Percent of patients achieving BP control (i.e., SBP<130mmHg)	Month 6
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 18	Percent of patients achieving BP control (i.e., SBP<130mmHg)	Month 18
Systolic blood pressure (mmHg) - Baseline	Mean SBP (mmHg)	Baseline
Systolic blood pressure (mmHg) - Month 6	Mean SBP (mmHg)	Month 6
Systolic blood pressure (mmHg) - Month 12	Mean SBP (mmHg)	Month 12
Systolic blood pressure (mmHg) - Month 18	Mean SBP (mmHg)	Month 18
Medication adherence - Hill-Bone medication adherence scale survey score - Baseline	Hill-Bone medication adherence scale survey - 14-item Hill-Bone Compliance Scale uses a 4-point Likert scale. Score range from 14-56. Higher scores indicates poorer adherence.	Baseline
Medication adherence - Hill-Bone medication adherence scale survey score - Month 12	Hill-Bone medication adherence scale survey - 14-item Hill-Bone Compliance Scale uses a 4-point Likert scale. Score range from 14-56. Higher scores indicates poorer adherence.	Month 12
Patient assessment of chronic illness care (PACIC) survey score - Baseline	The Patient assessment of chronic illness care (PACIC) survey assess implementation of the chronic care model from the patient perspective. The PACIC includes five subscales addressing specific domains: (1) patient activation; (2) delivery system design/decision support; (3) goal setting/tailoring; (4) problem solving/contextual counselling; and (5) follow-up/coordination. Patients rated care received from their healthcare team (e.g., physicians, nurses, physiotherapists, occupational therapists, social workers) during the past 6-months using a 5-point Likert scale (1 = 'never' to 5 = 'always'). Total and subscale scores (i.e., summed items completed within that scale) are averaged across items.	Baseline
Patient assessment of chronic illness care (PACIC) survey score - Month 12	The Patient assessment of chronic illness care (PACIC) survey assess implementation of the chronic care model from the patient perspective. The PACIC includes five subscales addressing specific domains: (1) patient activation; (2) delivery system design/decision support; (3) goal setting/tailoring; (4) problem solving/contextual counselling; and (5) follow-up/coordination. Patients rated care received from their healthcare team (e.g., physicians, nurses, physiotherapists, occupational therapists, social workers) during the past 6-months using a 5-point Likert scale (1 = 'never' to 5 = 'always'). Total and subscale scores (i.e., summed items completed within that scale) are averaged across items.	Month 12
Healthcare Utilization - Number of Acute Care Days - Baseline	Total days spent in an emergency department, inpatient hospital, or observation unit; number of physician office visits.	Baseline
Healthcare Utilization - Number of Acute Care Days - Month 12	Total days spent in an emergency department, inpatient hospital, or observation unit; number of physician office visits.	Month 12
Healthcare Utilization - Number of Acute Care Days - Month 24	Total days spent in an emergency department, inpatient hospital, or observation unit; number of physician office visits.	Month 24
Self-Management - Hypertension Self-Care Profile Score - Baseline	The hypertension self-care profile score encompassed self-care behaviors crucial to control blood pressure - Includes 3 scales (Behavior, Motivation, Self-efficacy) 20 items each that can be used together or independently. The Behavior scale assesses participant's self-care behaviors on a 4-point Likert scale. Mean scores range from 1-4 with higher scores indicating higher levels of self-care behavior. The Motivation scale assesses participant's self-care motivation on a 4-point Likert scale. Mean scores range from 1-4 with higher scores indicating higher levels of self-care motivation. The Self-efficacy scale assesses participant's self-care efficacy on a 4-point Likert scale. Mean scores range from 1-4 with higher scores indicating higher levels of self-efficacy. Higher scores indicate better self care behaviors - range from 60-240.	Baseline
Self-Management - Hypertension Self-Care Profile Score - Month 12	The hypertension self-care profile score encompassed self-care behaviors crucial to control blood pressure - Includes 3 scales (Behavior, Motivation, Self-efficacy) 20 items each that can be used together or independently. The Behavior scale assesses participant's self-care behaviors on a 4-point Likert scale. Mean scores range from 1-4 with higher scores indicating higher levels of self-care behavior. The Motivation scale assesses participant's self-care motivation on a 4-point Likert scale. Mean scores range from 1-4 with higher scores indicating higher levels of self-care motivation. The Self-efficacy scale assesses participant's self-care efficacy on a 4-point Likert scale. Mean scores range from 1-4 with higher scores indicating higher levels of self-efficacy. Higher scores indicate better self care behaviors - range from 60-240.	Month 12
20-Item Short Form Health Survey (SF-20) - Baseline	The SF-36 Total/Global/Overall Score, a global measure of health-related quality of life - scores range from 0-100 with higher scores denoting better quality of life	Baseline
20-Item Short Form Health Survey (SF-20) - Month 12	The SF-36 Total/Global/Overall Score, a global measure of health-related quality of life - scores range from 0-100 with higher scores denoting better quality of life	Month 12
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Baseline	Percent of patients achieving BP control (i.e., SBP<130mmHg)	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic intensification Score	The therapeutic intensity score is a number that reflects the number of medications and the percent of maximal dose of each medication. Numeric range 0-5.	Month 12

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Yhenneko J. Taylor, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: high blood pressure; remote blood pressure monitoring; African-American population
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: IRB00112245; BPS-2023C1-31377 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Patient-Centered Outcomes Research Institute (PCORI) Data Management and Data Sharing Policy, will prepare a Full Data Package (analyzable data set, full protocol, metadata, data dictionary, full statistical analysis plan and analytic code) for access by third parties. Per PCORI policy, the Full Data Package will be maintained at Atrium Health for 7 years, unless required by PCORI to be deposited in a separate repository.
• IPD Sharing 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).
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No