Status:
RECRUITING
Remote Hypertension Management for Black Patients
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Uncontrolled Hypertension
Eligibility:
All Genders
21-85 years
Phase:
NA
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...
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 prov...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
864 Patients enrolled
Trial Details
Trial ID
NCT06527794
Start Date
December 13 2024
End Date
September 1 2028
Last Update
June 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157