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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Anti-hypertensive medication adherence
Care coordination
Number of participants with a change in medical therapy
+6 more

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.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,351 Previous Clinical Trials
3,409,428 Total Patients Enrolled
11 Trials studying Rheumatoid Arthritis
2,129 Patients Enrolled for Rheumatoid Arthritis
National Institute on Minority Health and Health Disparities (NIMHD)NIH
374 Previous Clinical Trials
1,214,447 Total Patients Enrolled

Media Library

Blood pressure intervention arm Clinical Trial Eligibility Overview. Trial Name: NCT05760898 — N/A
Rheumatoid Arthritis Research Study Groups: Blood pressure intervention arm
Rheumatoid Arthritis Clinical Trial 2023: Blood pressure intervention arm Highlights & Side Effects. Trial Name: NCT05760898 — N/A
Blood pressure intervention arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05760898 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does enrollment for this experiment remain open?

"This medical trial, which was first published on March 20th of 2023, is not currently accepting participants. Even so, the website clinicaltrials.gov showcases 1134 other trials actively enrolling patients at this moment in time."

Answered by AI

What outcomes is this clinical trial seeking to obtain?

"This 6-month trial aims to gauge the feasibility of this intervention based on participant survey responses. Secondary objectives include monitoring rheumatoid arthritis disease activity with RAPID3 scores, measuring medication use for hypertension and RA over a biweekly period, and assessing anti-hypertensive drug adherence every 2 weeks during the study duration."

Answered by AI
~17 spots leftby Nov 2024