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Behavioral Intervention

Remote Management 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

Hypertension diagnosis

Be older than 18 years old

Must not have

Inability to provide informed consent or participate in study procedures. For example, conditions that limit ability to participate in phone visits or check blood pressures in at least one arm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 24

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two methods of managing high blood pressure in Black patients. One method involves monitoring blood pressure at home with the help of a pharmacist and community health worker. The other method involves regular clinic

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

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I have been diagnosed with high blood pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am able to give consent and participate in all study procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 24

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

20-Item Short Form Health Survey (SF-20) - Baseline

20-Item Short Form Health Survey (SF-20) - Month 12

Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 18

+14 more

Other study objectives

Medication dose amount - Baseline

Medication dose amount - Month 12

Therapeutic intensification dose

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met