Remote Hypertension Management for Black Patients

Official title

Remote Hypertension Tracking, Help, and Management to Reduce Disparities in Black Patients

Overview

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.

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.

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 outcome measures

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

Secondary outcome measures (12)

• Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Baseline [Time frame: Baseline]
• Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 6 [Time frame: Month 6]
• Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 18 [Time frame: Month 18]
• Systolic blood pressure (mmHg) - Baseline [Time frame: Baseline]
• Systolic blood pressure (mmHg) - Month 6 [Time frame: Month 6]
• Systolic blood pressure (mmHg) - Month 12 [Time frame: Month 12]
• Systolic blood pressure (mmHg) - Month 18 [Time frame: Month 18]
• Self-Management - Hypertension Self-Care Profile Score - Baseline [Time frame: Baseline]
• Self-Management - Hypertension Self-Care Profile Score - Month 12 [Time frame: Month 12]
• Medication adherence - Hill-Bone medication adherence scale survey score - Baseline [Time frame: Baseline]
• Medication adherence - Hill-Bone medication adherence scale survey score - Month 12 [Time frame: Month 12]
• Patient assessment of chronic illness care (PACIC) survey score - Baseline [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT06527794 · IRB00112245 · BPS-2023C1-31377

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗