Blood Pressure Intervention for Rheumatoid Arthritis

Overseen By Isaac Smith, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Other race, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals with rheumatoid arthritis (RA) who also face challenges with high blood pressure (hypertension). Researchers seek to identify factors that make blood pressure management difficult for these patients, as uncontrolled hypertension raises the risk of heart problems. Participants will use a home blood pressure monitor and report their results every two weeks. This trial suits those with both RA and uncontrolled hypertension who receive care from Duke Health System. As an unphased trial, it provides a unique opportunity to enhance understanding and improve hypertension management in RA patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on improving hypertension care for Black patients with rheumatoid arthritis, so it's best to discuss your medications with the trial team.

What prior data suggests that this blood pressure intervention is safe for rheumatoid arthritis patients?

Research shows that people with rheumatoid arthritis (RA) often struggle to manage high blood pressure. Common heart disease risk factors, like high blood pressure, frequently appear and remain poorly controlled in those with RA. Studies indicate that blood pressure can vary significantly from one doctor visit to the next for these patients. However, regular home monitoring and management of blood pressure lead to clear improvements.

This trial aims to help RA patients control their blood pressure by providing home monitors and instructions for use. Participants will track their blood pressure and share this information with the study team. This method has proven effective in managing blood pressure, leading to better health outcomes.

Overall, evidence suggests that using home blood pressure monitors with proper guidance is safe and helps RA patients manage their blood pressure more effectively. Research has not reported any serious problems from using these home monitoring devices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how managing blood pressure at home might impact rheumatoid arthritis (RA) symptoms. Unlike typical treatments for RA that focus on reducing inflammation directly, this approach looks at how controlling hypertension could play a role in overall disease management. The trial emphasizes patient empowerment by teaching participants to monitor their blood pressure at home and understand their readings, potentially leading to better RA management and quality of life. This innovative angle could reveal new insights into the connection between hypertension and RA, offering a fresh perspective on managing chronic conditions.

What evidence suggests that this blood pressure intervention is effective for rheumatoid arthritis?

Research has shown that managing blood pressure can improve the health of people with rheumatoid arthritis (RA). This is crucial because individuals with RA often experience higher blood pressure, particularly at night. In this trial, participants in the blood pressure intervention arm will use home blood pressure monitors and receive education to help them track and control their blood pressure more effectively. Studies have found that such interventions can reduce the risk of heart disease, which is common in these individuals. Overall, controlling blood pressure is a smart strategy to enhance health for people with RA. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You identify yourself as 'Black' or 'African American'.

You get medical care from both primary care and rheumatology departments at Duke Health System.

My high blood pressure is not under control.

Exclusion Criteria

Prisoners

I am under 18 years old.

I do not have rheumatoid arthritis or high blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Interviews with Black RA patients, rheumatology providers, and primary care providers to describe barriers to HTN care and develop an intervention

Not specified

Blood Pressure Monitoring

Participants use a home blood pressure monitor and record values at least three times per week for 3 months

3 months

Every 2 weeks, results are sent to the study team

Follow-up

Participants are monitored for safety and effectiveness after the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Blood pressure intervention arm

Trial Overview 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.

How Is the Trial Designed?

Group I: Blood pressure intervention arm Experimental Treatment 1 Intervention

The investigators will recruit 25 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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7461421/

Initiation of Disease-Modifying Therapies in Rheumatoid ... Blood pressure may improve with treatment of RA, particularly with methotrexate or hydroxychloroquine. Leflunomide use, in contrast, is associated with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05760898

Improving Hypertension Control in Rheumatoid Arthritis This pilot intervention will help achieve these goals by providing participants with home blood pressure monitors and teaching, improving patient-provider ...

3. jrheum.org jrheum.org/content/52/4/403

Association Between Rheumatoid Arthritis and Ambulatory ... The authors concluded that despite similar office measurements, 24-hour and nocturnal systolic BP measurements were higher in patients with RA ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496724194277

Blood pressure changes in patients with recent-onset ... To evaluate the effect of disease activity and antirheumatic treatment on blood pressure (BP) in patients with recent-onset rheumatoid arthritis (RA).

5. withpower.com withpower.com/trial/phase-arthritis-2-2023-09559

Blood Pressure Intervention for Rheumatoid Arthritis While specific data on the effectiveness of the blood pressure intervention treatment is not provided, controlling blood pressure is generally beneficial in ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38895593/

Risk factors for prevalent and incident hypertension in ... Early RA patients had a high incidence of hypertension with the highest risk in older patients with traditional cardiovascular risk factors.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4159667/

Long-term blood pressure variability in patients with ... Patients with RA had higher visit-to-visit systolic BP variability vs non-RA subjects. There was a significant decline in systolic BP variability after RA ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S277263202300034X

Association of cardiovascular risks in rheumatoid arthritis ... In a meta-analysis of 111,758 patients with 22,927 cardiovascular events, RA patients had a 50% higher risk of CVD death than the general population [51]. CVD ...