Improving Hypertension Control in Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood pressure intervention arm.
- Who it may be relevant to
- Registry conditions: Hypertension, Rheumatoid Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improving Hypertension Control for Patients With Rheumatoid Arthritis
Overview
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.
Interventions
- 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 prima
Primary outcome measures
- Intervention feasibility as measured by participant accrual rates [Time frame: 6 months]
- Intervention feasibility as measured by participant retention [Time frame: 6 months]
- Intervention feasibility as measured by adherence to blood pressure monitoring [Time frame: 6 months]
- Intervention feasibility as measured by adherence to survey reporting [Time frame: 6 months]
- Intervention feasibility as measured by sample characteristics [Time frame: 6 months]
- Intervention feasibility as measured by use of resources [Time frame: 6 months]
- Intervention feasibility as measured by sustainability of data collection procedures [Time frame: 6 months]
- Intervention acceptability as measured by qualitative interviews [Time frame: 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 [Time frame: 6 months]
- Barriers to and enablers of participating in the intervention as measured by qualitative interviews [Time frame: 6 months]
Secondary outcome measures (9)
- Participant blood pressure values [Time frame: 6 months]
- Participant rheumatoid arthritis disease activity [Time frame: 6 months]
- Participant medication use [Time frame: 6 months]
- Anti-hypertensive medication adherence [Time frame: 6 months]
- Perceived barriers to hypertension self-management [Time frame: 6 months]
- Provider engagement as measured by response to study team messages [Time frame: 6 months]
- Provider engagement as measured by interactions with participants [Time frame: 6 months]
- Care coordination [Time frame: 6 months]
- Number of participants with a change in medical therapy [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke Health System — Durham
Identifiers
NCT: NCT05760898 · PRO00112307 · 3U54MD012530-05S2