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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

RHYTHM (Remote Hypertension Tracking Help Management)
Behavioral
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
Enhanced usual care (UC)
Behavioral
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.

Treatment groups

864 Participants

are divided into 2 treatment groups

Group A: RHYTHM (Remote Hypertension Tracking Help Management)Experimental treatment 1 intervention

Group B: Enhanced usual care (UC)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

Month 12

Secondary outcomes

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)

Time frame

Baseline

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)

Time frame

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)

Time frame

Month 18

Systolic blood pressure (mmHg) - Baseline

Mean SBP (mmHg)

Time frame

Baseline

Other outcomes

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.

Time frame

Month 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov

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