Improving Hypertension Control for Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Intervention feasibility as measured by adherence to survey reporting
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •Uncontrolled hypertension
- •History of rheumatoid arthritis
- •Receive both primary care and rheumatology care from Duke Health System
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Blood pressure intervention arm (Behavioral)
结局指标
主要结局
Intervention feasibility as measured by adherence to survey reporting
时间窗: 6 months
Percentage of expected surveys completed by participants
Intervention feasibility as measured by participant retention
时间窗: 6 months
Percentage of participants who successfully complete the study
Intervention feasibility as measured by sustainability of data collection procedures
时间窗: 6 months
Financial and time commitments required to successfully collect participant surveys, blood pressure monitoring results, send information to providers, and monitor provider responses
Intervention feasibility as measured by sample characteristics
时间窗: 6 months
Description of sociodemographic characteristics of population, rheumatoid arthritis characteristics (eg, duration, medications, severity), and hypertension characteristics (eg, duration, medications, severity)
Perceived appropriateness of the intervention to address the health care disparity in HTN (hypertension) control for Black RA patients as measured by qualitative interviews
时间窗: 6 months
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.
Intervention feasibility as measured by adherence to blood pressure monitoring
时间窗: 6 months
Percentage of expected blood pressures reported by participants
Intervention feasibility as measured by use of resources
时间窗: 6 months
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 participant accrual rates
时间窗: 6 months
Rate at which participants are able to be successfully recruited
Intervention acceptability as measured by qualitative interviews
时间窗: 6 months
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.
Barriers to and enablers of participating in the intervention as measured by qualitative interviews
时间窗: 6 months
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.
次要结局
- Participant rheumatoid arthritis disease activity(6 months)
- Provider engagement as measured by response to study team messages(6 months)
- Care coordination(6 months)
- Participant blood pressure values(6 months)
- Participant medication use(6 months)
- Perceived barriers to hypertension self-management(6 months)
- Anti-hypertensive medication adherence(6 months)
- Provider engagement as measured by interactions with participants(6 months)
- Number of participants with a change in medical therapy(6 months)