Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT05760898

Conditions

Hypertension

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood pressure intervention arm

Study Details

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

Study ID

NCT05760898

Start date

Jan 16, 2026

Status verified date

Aug, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Blood pressure intervention arm

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.

Interventions

Blood pressure intervention arm

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.

Primary outcome measure

  • Intervention feasibility as measured by participant accrual rates [ Time Frame: 6 months ]
  • Intervention feasibility as measured by participant retention [ Time Frame: 6 months ]
  • Intervention feasibility as measured by adherence to blood pressure monitoring [ Time Frame: 6 months ]
  • Intervention feasibility as measured by adherence to survey reporting [ Time Frame: 6 months ]
  • Intervention feasibility as measured by sample characteristics [ Time Frame: 6 months ]
  • Intervention feasibility as measured by use of resources [ Time Frame: 6 months ]
  • Intervention feasibility as measured by sustainability of data collection procedures [ Time Frame: 6 months ]
  • Intervention acceptability as measured by qualitative interviews [ Time Frame: 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 [ Time Frame: 6 months ]
  • Barriers to and enablers of participating in the intervention as measured by qualitative interviews [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Isaac Smith, MD

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

Locations

Duke Health System

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Edna Scarlett

919-684-6150edna.scarlett@duke.edu

Isaac Smith, MD

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

Principal Investigator:

Isaac Smith, MD

More Information

Sponsor

Duke University

Last update posted

Feb 6, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-02-06.