Improving Hypertension Control in Rheumatoid Arthritis

NCT05760898 | Recruiting

• 2 other identifiers: PRO001123073U54MD012530-05S2
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (10)

• Intervention feasibility as measured by participant accrual rates

  Rate at which participants are able to be successfully recruited

  6 months

• Intervention feasibility as measured by participant retention

  Percentage of participants who successfully complete the study

  6 months

• Intervention feasibility as measured by adherence to blood pressure monitoring

  Percentage of expected blood pressures reported by participants

  6 months

• Intervention feasibility as measured by adherence to survey reporting

  Percentage of expected surveys completed by participants

  6 months

• Intervention feasibility as measured by sample characteristics

  Description of sociodemographic characteristics of population, rheumatoid arthritis characteristics (eg, duration, medications, severity), and hypertension characteristics (eg, duration, medications, severity)

  6 months

• Intervention feasibility as measured by use of resources

  Cost of participant recruitment, education, blood pressure monitors, participant compensation, research coordinator time and cost needed to collect data, and statistical analysis

  6 months

• Intervention feasibility as measured by sustainability of data collection procedures

  Financial and time commitments required to successfully collect participant surveys, blood pressure monitoring results, send information to providers, and monitor provider responses

  6 months

• Intervention acceptability as measured by qualitative interviews

  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.

  6 months

• Perceived appropriateness of the intervention to address the health care disparity in HTN (hypertension) control for Black RA patients as measured by qualitative interviews

  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.

  6 months

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

  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.

  6 months

Secondary Outcomes (9)

• Participant blood pressure values

  6 months

• Participant rheumatoid arthritis disease activity

  6 months

• Participant medication use

  6 months

• Anti-hypertensive medication adherence

  6 months

• Perceived barriers to hypertension self-management

  6 months

Study Arms (1)

Blood pressure intervention arm

EXPERIMENTAL

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.

Behavioral: Blood pressure intervention arm

Interventions

Blood pressure intervention arm BEHAVIORAL

The intervention will focus on empowering patients to actively participate in their HTN care, facilitating patient-provider communication, and creating a cohesive care team to close the coordination loop for HTN management. This pilot intervention will help achieve these goals by providing participants with home blood pressure monitors and teaching, improving patient-provider communication regarding blood pressure and RA management, and initiating care coordination between rheumatology and primary care providers.

Blood pressure intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Duke Health System

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Hypertension; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Isaac Smith, MD

CONTACT

919-613-2243; isaac.smith063@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 9, 2023
• Study Start: January 16, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 6, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)