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NCT Number: NCT05760898

Improving Hypertension Control in Rheumatoid Arthritis

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.

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Key information

Conditions

Hypertension Arthritis Arthritis, Rheumatoid Autoimmune Diseases Cardiovascular Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Intervention feasibility as measured by participant accrual rates

    Time frame: 6 months

    Rate at which participants are able to be successfully recruited

  2. Intervention feasibility as measured by participant retention

    Time frame: 6 months

    Percentage of participants who successfully complete the study

  3. Intervention feasibility as measured by adherence to blood pressure monitoring

    Time frame: 6 months

    Percentage of expected blood pressures reported by participants

  4. Intervention feasibility as measured by adherence to survey reporting

    Time frame: 6 months

    Percentage of expected surveys completed by participants

  5. Intervention feasibility as measured by sample characteristics

    Time frame: 6 months

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

  6. Intervention feasibility as measured by use of resources

    Time frame: 6 months

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

  7. Intervention feasibility as measured by sustainability of data collection procedures

    Time frame: 6 months

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

  8. Intervention acceptability as measured by qualitative interviews

    Time frame: 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.

  9. 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

    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.

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

    Time frame: 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 outcomes

  1. Participant blood pressure values

    Time frame: 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

  2. Participant rheumatoid arthritis disease activity

    Time frame: 6 months

    Rheumatoid arthritis disease activity self-reported by participants using the RAPID3 score every 2 weeks for 6 months

  3. Participant medication use

    Time frame: 6 months

    Medication use for hypertension and rheumatoid arthritis reported by participants every 2 weeks for 6 months

  4. Anti-hypertensive medication adherence

    Time frame: 6 months

    Participant self-reported adherence percentage to anti-hypertensive medications collected every 2 weeks for 6 months

  5. Perceived barriers to hypertension self-management

    Time frame: 6 months

    Participant self-reported barriers to hypertension self-management collected every 2 weeks for 6 months

  6. Provider engagement as measured by response to study team messages

    Time frame: 6 months

    Frequency and type of provider responses to study team messages

  7. Provider engagement as measured by interactions with participants

    Time frame: 6 months

    Frequency and type of provider interactions with participants after receiving a study team message

  8. Care coordination

    Time frame: 6 months

    Activation of care team members

  9. Number of participants with a change in medical therapy

    Time frame: 6 months

    Changes in anti-hypertensive or RA therapies

Study contacts

Contact information is provided by the study sponsor or research team.

Isaac Smith, MD

CONTACT

[email protected]

919-613-2243

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Improving Hypertension Control for Patients With Rheumatoid Arthritis

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2023
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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