Reducing Hypertension Disparities in Rheumatoid Arthritis

Reducing Disparities in Hypertension Care for Patients With Rheumatoid Arthritis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Rheumatoid Arthritis
• Intervention / Treatment: Behavioral: Blood pressure intervention arm

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention feasibility as measured by participant accrual rates	Rate at which participants are able to be successfully recruited	6 months
Intervention feasibility as measured by participant retention	Percentage of participants who successfully complete the study	6 months
Intervention feasibility as measured by adherence to blood pressure monitoring	Percentage of expected blood pressures reported by participants	6 months
Intervention feasibility as measured by adherence to survey reporting	Percentage of expected surveys completed by participants	6 months
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Participant medication use	Medication use for hypertension and rheumatoid arthritis reported by participants every 2 weeks for 6 months	6 months
Anti-hypertensive medication adherence	Participant self-reported adherence percentage to anti-hypertensive medications collected every 2 weeks for 6 months	6 months
Perceived barriers to hypertension self-management	Participant self-reported barriers to hypertension self-management collected every 2 weeks for 6 months	6 months
Provider engagement as measured by response to study team messages	Frequency and type of provider responses to study team messages	6 months
Provider engagement as measured by interactions with participants	Frequency and type of provider interactions with participants after receiving a study team message	6 months
Care coordination	Activation of care team members	6 months
Number of participants with a change in medical therapy	Changes in anti-hypertensive or RA therapies	6 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): November 14, 2024
• Study Completion (Estimated): November 14, 2024

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Hypertension; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: PRO00112307; 3U54MD012530-05S2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No