Reducing Hypertension Disparities in Rheumatoid Arthritis

Hypertension Clinical Trial

Official title:

Reducing Disparities in Hypertension Care for Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05760898
• Other study ID #: PRO00112307
• Secondary ID: 3U54MD012530-05S
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: November 14, 2024

Study information

• Verified date: June 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: November 14, 2024
• Est. primary completion date: November 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Hypertension
• Rheumatoid Arthritis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Duke Health System	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention feasibility as measured by participant accrual rates	Rate at which participants are able to be successfully recruited	6 months
Primary	Intervention feasibility as measured by participant retention	Percentage of participants who successfully complete the study	6 months
Primary	Intervention feasibility as measured by adherence to blood pressure monitoring	Percentage of expected blood pressures reported by participants	6 months
Primary	Intervention feasibility as measured by adherence to survey reporting	Percentage of expected surveys completed by participants	6 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Participant blood pressure values	Systolic and diastolic blood pressures taken at least three times per week and reported to the study team every 2 weeks for 6 months	6 months
Secondary	Participant rheumatoid arthritis disease activity	Rheumatoid arthritis disease activity self-reported by participants using the RAPID3 score every 2 weeks for 6 months	6 months
Secondary	Participant medication use	Medication use for hypertension and rheumatoid arthritis reported by participants every 2 weeks for 6 months	6 months
Secondary	Anti-hypertensive medication adherence	Participant self-reported adherence percentage to anti-hypertensive medications collected every 2 weeks for 6 months	6 months
Secondary	Perceived barriers to hypertension self-management	Participant self-reported barriers to hypertension self-management collected every 2 weeks for 6 months	6 months
Secondary	Provider engagement as measured by response to study team messages	Frequency and type of provider responses to study team messages	6 months
Secondary	Provider engagement as measured by interactions with participants	Frequency and type of provider interactions with participants after receiving a study team message	6 months
Secondary	Care coordination	Activation of care team members	6 months
Secondary	Number of participants with a change in medical therapy	Changes in anti-hypertensive or RA therapies	6 months