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Behavioral Intervention

Enhanced usual care (UC) for High Blood Pressure (RHYTHM-B Trial)

N/A
Waitlist Available
Led By Yhenneko J. Taylor, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Black or African American race
* Hypertension diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 24
Awards & highlights

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.

Who is the study for?
This trial is for Black patients who have high blood pressure that isn't well-controlled. Participants will need to be comfortable with using a home blood pressure monitor and engaging in remote communication for the duration of the study.
What is being tested?
The study is testing two methods of managing high blood pressure. One group will use a home BP telemonitoring system with support from pharmacists and community health workers, while the other will receive standard clinic care plus a home BP monitor.
What are the potential side effects?
Since this trial involves non-drug interventions (telemonitoring and usual care), there are no direct side effects like those seen with medications. However, participants may experience stress or anxiety related to self-monitoring or changes in their healthcare routine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 12
Secondary study objectives
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 18
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 6
Consumer assessment and healthcare providers and systems adult survey score - Baseline
+17 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: RHYTHM (Remote Hypertension Tracking Help Management)Experimental Treatment1 Intervention
home blood pressure telemonitoring with remote medication management and social support, lifestyle education and connection to community resources to address social needs
Group II: Enhanced usual care (UC)Experimental Treatment1 Intervention
standardized packet with evidence-based hypertension education material and a blood pressure monitor to complete blood pressure measurements at home

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,258 Previous Clinical Trials
1,011,084 Total Patients Enrolled
Yhenneko J. Taylor, PhDPrincipal InvestigatorWake Forest University Health Sciences
~576 spots leftby Sep 2028
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