Clinical trial NCT06527794: Remote Hypertension Management for Black Patients
Official title: Remote Hypertension Tracking, Help, and Management to Reduce Disparities in Black Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uncontrolled Hypertension
Keywords: high blood pressure
African-American population
remote blood pressure monitoring
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-07-30
Enrollment: 864
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

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.

Primary outcomes:
measure: Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Baseline
timeFrame: Baseline
measure: Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 6
timeFrame: Month 6
measure: Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 18
timeFrame: Month 18
measure: Systolic blood pressure (mmHg) - Baseline
timeFrame: Baseline
measure: Systolic blood pressure (mmHg) - Month 6
timeFrame: Month 6
measure: Systolic blood pressure (mmHg) - Month 12
timeFrame: Month 12
measure: Systolic blood pressure (mmHg) - Month 18
timeFrame: Month 18
measure: Self-Management - Hypertension Self-Care Profile Score - Baseline
timeFrame: Baseline
measure: Self-Management - Hypertension Self-Care Profile Score - Month 12
timeFrame: Month 12
measure: Medication adherence - Hill-Bone medication adherence scale survey score - Baseline
timeFrame: Baseline
measure: Medication adherence - Hill-Bone medication adherence scale survey score - Month 12
timeFrame: Month 12
measure: Patient assessment of chronic illness care (PACIC) survey score - Baseline
timeFrame: Baseline
measure: Patient assessment of chronic illness care (PACIC) survey score - Month 12
timeFrame: Month 12
measure: 20-Item Short Form Health Survey (SF-20) - Baseline
timeFrame: Baseline
measure: 20-Item Short Form Health Survey (SF-20) - Month 12
timeFrame: Month 12
measure: Healthcare Utilization - Number of Acute Care Days - Baseline
timeFrame: Baseline
measure: Healthcare Utilization - Number of Acute Care Days - Month 12
timeFrame: Month 12
measure: Healthcare Utilization - Number of Acute Care Days - Month 24
timeFrame: Month 24
Other outcomes:
measure: Therapeutic intensification Score
timeFrame: Month 12
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Yhenneko J. Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References: