Reducing Hypertension Disparities in Rheumatoid Arthritis
- Conditions
- HypertensionRheumatoid Arthritis
- Interventions
- Behavioral: Blood pressure intervention arm
- 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, particularly in Black patients. Traditional CAD risk factors like hypertension (HTN) are both very common and poorly controlled among Black RA patients. Disparities in RA disease activity further increase the risk of CAD in this population. Black patients face significant barriers when seeking RA care, and the investigators suspect similar challenges affect HTN care in this population. The goals of this project are to identify and address barriers to HTN care in patients with RA to reduce disparities in HTN and CAD outcomes for Black RA patients.
Interviews with Black RA patients, rheumatology providers, and primary care providers in the Duke University Health System will be conducted to describe barriers to HTN care in Black RA patients. Interviews will focus on access to care, patient-provider communication, coordination of care, and the challenges of managing HTN in patients with RA. These interviews will help us to develop an intervention that will focus on improving uncontrolled HTN in Black RA patients. The investigators plan to do this by empowering Black RA patients to actively participate in their HTN care, improving patient-provider communication, and improving coordination between primary care and rheumatology providers. If successful, our intervention has the potential to reduce rates of CAD and associated death for Black RA patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 25
- 18 years old or older
- Race self-identified as "Black" or "African American"
- Uncontrolled hypertension
- History of rheumatoid arthritis
- Receive both primary care and rheumatology care from Duke Health System
- Age less than 18 years old
- Other self-identified race
- 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
- Arm && Interventions
Group Intervention Description Blood pressure intervention arm Blood pressure intervention arm 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.
- 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