25 Participants Needed

Blood Pressure Intervention for Rheumatoid Arthritis

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Rheumatoid arthritis (RA) is a autoimmune disease associated with an increased risk of developing coronary artery disease (CAD) and premature death, particularly in Black patients. Traditional CAD risk factors like hypertension (HTN) are both very common and poorly controlled among Black RA patients. Disparities in RA disease activity further increase the risk of CAD in this population. Black patients face significant barriers when seeking RA care, and the investigators suspect similar challenges affect HTN care in this population. The goals of this project are to identify and address barriers to HTN care in patients with RA to reduce disparities in HTN and CAD outcomes for Black RA patients. Interviews with Black RA patients, rheumatology providers, and primary care providers in the Duke University Health System will be conducted to describe barriers to HTN care in Black RA patients. Interviews will focus on access to care, patient-provider communication, coordination of care, and the challenges of managing HTN in patients with RA. These interviews will help us to develop an intervention that will focus on improving uncontrolled HTN in Black RA patients. The investigators plan to do this by empowering Black RA patients to actively participate in their HTN care, improving patient-provider communication, and improving coordination between primary care and rheumatology providers. If successful, our intervention has the potential to reduce rates of CAD and associated death for Black 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 data supports the effectiveness of the blood pressure intervention treatment for rheumatoid arthritis?

The research highlights that managing blood pressure is crucial for rheumatoid arthritis patients due to their increased risk of cardiovascular disease. While specific data on the effectiveness of the blood pressure intervention treatment is not provided, controlling blood pressure is generally beneficial in reducing cardiovascular risks in these patients.12345

How does the blood pressure intervention treatment for rheumatoid arthritis differ from other treatments?

This treatment is unique because it targets both blood pressure control and inflammation, which are important in managing rheumatoid arthritis and reducing cardiovascular risk. It may involve the use of renin-angiotensin-system (RAS) inhibitors, which have a dual effect of lowering blood pressure and providing anti-inflammatory benefits, potentially offering protection against heart attacks in this patient group.12367

Eligibility Criteria

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'.
I am 18 years old or older.
You get medical care from both primary care and rheumatology departments at Duke Health System.
See 2 more

Exclusion Criteria

Prisoners
I am under 18 years old.
I do not have rheumatoid arthritis or high blood pressure.
See 4 more

Timeline

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

Treatment Details

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.
Participant Groups
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.

Find a Clinic Near You

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+

References

Blood pressure changes in patients with recent-onset rheumatoid arthritis treated with four different treatment strategies: a post hoc analysis from the BeSt trial. [2022]
Arterial hypertension assessed "out-of-office" in a contemporary cohort of rheumatoid arthritis patients free of cardiovascular disease is characterized by high prevalence, low awareness, poor control and increased vascular damage-associated "white coat" phenomenon. [2022]
Prevalence and associations of hypertension and its control in patients with rheumatoid arthritis. [2022]
Blood Pressure Trends in Patients With Seropositive Rheumatoid Arthritis Compared With Controls Without Rheumatoid Arthritis: A Retrospective Cohort Study. [2022]
Long-term exposure to medium-dose glucocorticoid therapy associates with hypertension in patients with rheumatoid arthritis. [2022]
Primary prevention of myocardial infarction with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in hypertensive patients with rheumatoid arthritis-A nationwide cohort study. [2018]
FEATURES OF THE DAILY PROFILE OF ARTERIAL BLOOD PRESSURE IN PATIENTS WITH RHEUMATOID ARTHRITIS IN COMBINATION WITH ARTERIAL HYPERTENSION. [2023]