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Blood Pressure Intervention for Rheumatoid Arthritis

N/A

Waitlist Available

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years old or older

Uncontrolled hypertension

Must not have

Age less than 18 years old

Healthy volunteers without rheumatoid arthritis and hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study ways to reduce high risk of CAD & premature death in Black RA patients by improving hypertension care.

Who is the study for?

This trial is for Black or African American adults over 18 with uncontrolled high blood pressure and rheumatoid arthritis, who are receiving care from the Duke Health System. It's not open to those under 18, other races, people without RA and hypertension, pregnant women, prisoners, or anyone unable to consent due to cognitive impairment.

What is being tested?

The study aims to reduce hypertension disparities in Black patients with rheumatoid arthritis by developing an intervention focused on patient empowerment in HTN care, enhancing communication between patients and providers, and better coordination of primary and rheumatology care.

What are the potential side effects?

Since this trial focuses on a non-drug intervention involving patient education and healthcare system improvements rather than medication testing directly, it may not have typical drug side effects. However, stress or anxiety related to changes in healthcare management could occur.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My high blood pressure is not under control.

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I have a history of rheumatoid arthritis.

Exclusion Criteria

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

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I am under 18 years old.

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I do not have rheumatoid arthritis or high blood pressure.

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I am unable to understand or agree to the study because of cognitive issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Barriers to and enablers of participating in the intervention as measured by qualitative interviews

Intervention acceptability as measured by qualitative interviews

Intervention feasibility as measured by adherence to blood pressure monitoring

+7 more

Secondary study objectives

Anti-hypertensive medication adherence

Care coordination

Number of participants with a change in medical therapy

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Blood pressure intervention armExperimental Treatment1 Intervention

The investigators will recruit 25 Black RA patients with HTN for the study. Participants will be provided with a home blood pressure monitor, teaching from nursing staff regarding the correct use of the monitor, and a guide to help interpret normal and elevated blood pressure values. Participants will be instructed to obtain and record blood pressure values at least three times per week over the course of 3 months. Every 2 weeks, these results will be sent to the study team, and participants will complete a brief survey regarding other factors that may influence blood pressure control, including RA disease activity (RAPID3 score), pain, current use of acute RA therapies, anti-hypertensive medication use, anti-hypertensive medication adherence, and current perceived barriers to HTN self-management.

0 / 6Eligibility criteria met