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Reducing Hypertension Disparities in Rheumatoid Arthritis

Primary Purpose

Hypertension, Rheumatoid Arthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood pressure intervention arm
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blood pressure intervention arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Intervention feasibility as measured by participant accrual rates
Rate at which participants are able to be successfully recruited
Intervention feasibility as measured by participant retention
Percentage of participants who successfully complete the study
Intervention feasibility as measured by adherence to blood pressure monitoring
Percentage of expected blood pressures reported by participants
Intervention feasibility as measured by adherence to survey reporting
Percentage of expected surveys completed by participants
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)
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
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
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.
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.
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.

Secondary Outcome Measures

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
Participant rheumatoid arthritis disease activity
Rheumatoid arthritis disease activity self-reported by participants using the RAPID3 score every 2 weeks for 6 months
Participant medication use
Medication use for hypertension and rheumatoid arthritis reported by participants every 2 weeks for 6 months
Anti-hypertensive medication adherence
Participant self-reported adherence percentage to anti-hypertensive medications collected every 2 weeks for 6 months
Perceived barriers to hypertension self-management
Participant self-reported barriers to hypertension self-management collected every 2 weeks for 6 months
Provider engagement as measured by response to study team messages
Frequency and type of provider responses to study team messages
Provider engagement as measured by interactions with participants
Frequency and type of provider interactions with participants after receiving a study team message
Care coordination
Activation of care team members
Number of participants with a change in medical therapy
Changes in anti-hypertensive or RA therapies

Full Information

First Posted
February 9, 2023
Last Updated
September 29, 2023
Sponsor
Duke University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05760898
Brief Title
Reducing Hypertension Disparities in Rheumatoid Arthritis
Official Title
Reducing Disparities in Hypertension Care for Patients With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
November 14, 2024 (Anticipated)
Study Completion Date
November 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood pressure intervention arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Blood pressure intervention arm
Intervention Description
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 Outcome Measure Information:
Title
Intervention feasibility as measured by participant accrual rates
Description
Rate at which participants are able to be successfully recruited
Time Frame
6 months
Title
Intervention feasibility as measured by participant retention
Description
Percentage of participants who successfully complete the study
Time Frame
6 months
Title
Intervention feasibility as measured by adherence to blood pressure monitoring
Description
Percentage of expected blood pressures reported by participants
Time Frame
6 months
Title
Intervention feasibility as measured by adherence to survey reporting
Description
Percentage of expected surveys completed by participants
Time Frame
6 months
Title
Intervention feasibility as measured by sample characteristics
Description
Description of sociodemographic characteristics of population, rheumatoid arthritis characteristics (eg, duration, medications, severity), and hypertension characteristics (eg, duration, medications, severity)
Time Frame
6 months
Title
Intervention feasibility as measured by use of resources
Description
Cost of participant recruitment, education, blood pressure monitors, participant compensation, research coordinator time and cost needed to collect data, and statistical analysis
Time Frame
6 months
Title
Intervention feasibility as measured by sustainability of data collection procedures
Description
Financial and time commitments required to successfully collect participant surveys, blood pressure monitoring results, send information to providers, and monitor provider responses
Time Frame
6 months
Title
Intervention acceptability as measured by qualitative interviews
Description
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.
Time Frame
6 months
Title
Perceived appropriateness of the intervention to address the health care disparity in HTN (hypertension) control for Black RA patients as measured by qualitative interviews
Description
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.
Time Frame
6 months
Title
Barriers to and enablers of participating in the intervention as measured by qualitative interviews
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Participant blood pressure values
Description
Systolic and diastolic blood pressures taken at least three times per week and reported to the study team every 2 weeks for 6 months
Time Frame
6 months
Title
Participant rheumatoid arthritis disease activity
Description
Rheumatoid arthritis disease activity self-reported by participants using the RAPID3 score every 2 weeks for 6 months
Time Frame
6 months
Title
Participant medication use
Description
Medication use for hypertension and rheumatoid arthritis reported by participants every 2 weeks for 6 months
Time Frame
6 months
Title
Anti-hypertensive medication adherence
Description
Participant self-reported adherence percentage to anti-hypertensive medications collected every 2 weeks for 6 months
Time Frame
6 months
Title
Perceived barriers to hypertension self-management
Description
Participant self-reported barriers to hypertension self-management collected every 2 weeks for 6 months
Time Frame
6 months
Title
Provider engagement as measured by response to study team messages
Description
Frequency and type of provider responses to study team messages
Time Frame
6 months
Title
Provider engagement as measured by interactions with participants
Description
Frequency and type of provider interactions with participants after receiving a study team message
Time Frame
6 months
Title
Care coordination
Description
Activation of care team members
Time Frame
6 months
Title
Number of participants with a change in medical therapy
Description
Changes in anti-hypertensive or RA therapies
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Duke Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Reducing Hypertension Disparities in Rheumatoid Arthritis

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