Improving Hypertension Control in Rheumatoid Arthritis

NCT ID: NCT05760898

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-17

Study Completion Date

2025-12-31

Brief Summary

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Rheumatoid arthritis (RA) is a autoimmune disease associated with an increased risk of developing coronary artery disease (CAD) and premature death,. Traditional CAD risk factors like hypertension (HTN) are both very common and poorly controlled among RA patients. Patients with RA face significant challenges in controlling HTN. The goal of this project is to identify barriers to HTN care in patients with RA to reduce CAD events.

Detailed Description

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Conditions

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Hypertension Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Blood pressure intervention arm

The investigators will recruit 25 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.

Group Type EXPERIMENTAL

Blood pressure intervention arm

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years old or older
* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Duke Health System

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Isaac Smith, MD

Role: CONTACT

919-613-2243

Facility Contacts

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Edna Scarlett

Role: primary

919-684-6150

Isaac Smith, MD

Role: backup

919-613-2243

Other Identifiers

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3U54MD012530-05S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO00112307

Identifier Type: -

Identifier Source: org_study_id