Clinical trial NCT05760898: Reducing Hypertension Disparities in Rheumatoid Arthritis
Official title: Reducing Disparities in Hypertension Care for Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Rheumatoid Arthritis
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-03-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Intervention feasibility as measured by participant accrual rates
timeFrame: 6 months
measure: Intervention feasibility as measured by participant retention
timeFrame: 6 months
measure: Intervention feasibility as measured by adherence to blood pressure monitoring
timeFrame: 6 months
measure: Intervention feasibility as measured by adherence to survey reporting
timeFrame: 6 months
measure: Intervention feasibility as measured by sample characteristics
timeFrame: 6 months
measure: Intervention feasibility as measured by use of resources
timeFrame: 6 months
measure: Intervention feasibility as measured by sustainability of data collection procedures
timeFrame: 6 months
measure: Intervention acceptability as measured by qualitative interviews
timeFrame: 6 months
measure: Perceived appropriateness of the intervention to address the health care disparity in HTN (hypertension) control for Black RA patients as measured by qualitative interviews
timeFrame: 6 months
measure: Barriers to and enablers of participating in the intervention as measured by qualitative interviews
timeFrame: 6 months
Secondary outcomes:
measure: Participant blood pressure values
timeFrame: 6 months
measure: Participant rheumatoid arthritis disease activity
timeFrame: 6 months
measure: Participant medication use
timeFrame: 6 months
measure: Anti-hypertensive medication adherence
timeFrame: 6 months
measure: Perceived barriers to hypertension self-management
timeFrame: 6 months
measure: Provider engagement as measured by response to study team messages
timeFrame: 6 months
measure: Provider engagement as measured by interactions with participants
timeFrame: 6 months
measure: Care coordination
timeFrame: 6 months
measure: Number of participants with a change in medical therapy
timeFrame: 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Health System
state: North Carolina
Study officials:
References: