150 Participants NeededMy employer runs this trial

Self-Measured Blood Pressure Monitoring for High Blood Pressure

Recruiting at 7 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to identify what cuff delivery and BP log return modality most effectively achieve successful delivery of a self-measured blood pressure (SMBP) intervention in routine care, among adult primary care patients with uncontrolled hypertension?

Who Is on the Research Team?

RK

Rasha Khatib, PhD

Principal Investigator

Advocate Health

Are You a Good Fit for This Trial?

This trial is for adults who have high blood pressure that isn't well controlled and are receiving care in a primary care setting. Participants should be able to use a home blood pressure monitor.

Inclusion Criteria

I was diagnosed with high blood pressure before my clinic visit.
Scheduled for and attends an in-person visit with a participating clinician at a study clinic
Elevated BP documented in Epic during rooming or the clinic visit before study enrollment, defined as systolic BP >=140 mmHg or diastolic BP >=90 mmHg
See 1 more

Exclusion Criteria

Visit is canceled, rescheduled, or the patient does not attend the visit
I do not want help getting a blood pressure cuff.
Patient already has a usable home BP cuff provided through insurance within the past 5 years
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Intervention

Participants receive blood pressure cuffs and training through one of four randomized pathways

2 weeks
1 visit (in-person or virtual)

Follow-up

Participants are monitored for successful delivery and training completion, and document blood pressure readings

3 weeks
Routine clinic processes for documenting or reviewing SMBP readings

Extended Follow-up

Monitoring of changes in systolic blood pressure and medication adjustments

up to 90 days

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares different ways of giving patients home blood pressure cuffs (in-person or by mail) and training them (hands-on or written instructions) to see which method helps people best measure their own blood pressure at home.

How Is the Trial Designed?

4

Treatment groups

Active Control

Group I: In-clinic cuff distribution - Enhanced Return ConversationActive Control1 Intervention
Group II: Mail-order cuff delivery - Enhanced Return ConversationActive Control1 Intervention
Group III: Mail-order cuff delivery - Written instructionsActive Control1 Intervention
Group IV: In-clinic cuff distribution - Written instructionsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+