Improving Hypertension Control in Rheumatoid Arthritis

Not Applicable

Recruiting

• Conditions: Hypertension; Rheumatoid Arthritis

• Registration Number: NCT05760898
• Lead Sponsor: Duke University

Brief Summary

Rheumatoid arthritis (RA) is a autoimmune disease associated with an increased risk of developing coronary artery disease (CAD) and premature death,. Traditional CAD risk factors like hypertension (HTN) are both very common and poorly controlled among RA patients. Patients with RA face significant challenges in controlling HTN. The goal of this project is to identify barriers to HTN care in patients with RA to reduce CAD events.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-03-09
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-01
• Last Update Posted: 2025-08-06
• Study Start: 2025-08-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 18 years old or older
• Uncontrolled hypertension
• History of rheumatoid arthritis
• Receive both primary care and rheumatology care from Duke Health System

Exclusion Criteria

• Age less than 18 years old
• Healthy volunteers without rheumatoid arthritis and hypertension
• Do not receive both primary care and rheumatology care from Duke Health System
• Cognitive impairment with lack the capacity to consent to study participation
• Pregnant women
• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Intervention feasibility as measured by adherence to survey reporting	6 months	Percentage of expected surveys completed by participants
Intervention feasibility as measured by participant retention	6 months	Percentage of participants who successfully complete the study
Intervention feasibility as measured by sustainability of data collection procedures	6 months	Financial and time commitments required to successfully collect participant surveys, blood pressure monitoring results, send information to providers, and monitor provider responses
Intervention feasibility as measured by sample characteristics	6 months	Description of sociodemographic characteristics of population, rheumatoid arthritis characteristics (eg, duration, medications, severity), and hypertension characteristics (eg, duration, medications, severity)
Perceived appropriateness of the intervention to address the health care disparity in HTN (hypertension) control for Black RA patients as measured by qualitative interviews	6 months	Qualitative interviews will be performed at the end of the pilot intervention with all study participants to assess the perceived appropriateness of the intervention to address the health care disparity in HTN control for Black RA patients. Rheumatology and primary care providers caring for study participants will also be invited to comment on the appropriateness of the intervention.
Intervention feasibility as measured by adherence to blood pressure monitoring	6 months	Percentage of expected blood pressures reported by participants
Intervention feasibility as measured by use of resources	6 months	Cost of participant recruitment, education, blood pressure monitors, participant compensation, research coordinator time and cost needed to collect data, and statistical analysis
Intervention feasibility as measured by participant accrual rates	6 months	Rate at which participants are able to be successfully recruited
Intervention acceptability as measured by qualitative interviews	6 months	Qualitative interviews will be performed at the end of the pilot intervention with all study participants to assess the acceptability of the intervention. Rheumatology and primary care providers caring for study participants will also be invited to comment on the acceptability of the intervention.
Barriers to and enablers of participating in the intervention as measured by qualitative interviews	6 months	Qualitative interviews will be performed at the end of the pilot intervention with all study participants to assess barriers to and enablers of participating in the intervention.

Secondary Outcome Measures

Name	Time	Method
Participant rheumatoid arthritis disease activity	6 months	Rheumatoid arthritis disease activity self-reported by participants using the RAPID3 score every 2 weeks for 6 months
Provider engagement as measured by response to study team messages	6 months	Frequency and type of provider responses to study team messages
Care coordination	6 months	Activation of care team members
Participant blood pressure values	6 months	Systolic and diastolic blood pressures taken at least three times per week and reported to the study team every 2 weeks for 6 months
Participant medication use	6 months	Medication use for hypertension and rheumatoid arthritis reported by participants every 2 weeks for 6 months
Perceived barriers to hypertension self-management	6 months	Participant self-reported barriers to hypertension self-management collected every 2 weeks for 6 months
Anti-hypertensive medication adherence	6 months	Participant self-reported adherence percentage to anti-hypertensive medications collected every 2 weeks for 6 months
Provider engagement as measured by interactions with participants	6 months	Frequency and type of provider interactions with participants after receiving a study team message
Number of participants with a change in medical therapy	6 months	Changes in anti-hypertensive or RA therapies

Trial Locations

Locations (1)

Duke Health System; 🇺🇸 Durham, North Carolina, United States