Remote Hypertension Management for Black Patients
ConditionUncontrolled Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- RHYTHM (Remote Hypertension Tracking Help Management)
- Enhanced usual care (UC)
Treatment groups
864 Participants
are divided into 2 treatment groupsSponsors and collaborators
Wake Forest University Health Sciences
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov