Optimization of Hyperlipidemia Management Among Patients With Rheumatoid Arthritis: A Patient-centered Intervention Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Number of Subjects With Lipids Checked (Available Now Through National Laboratory Chain) or That Reported Having Their Lipids Checked by Their 1-week or 3-month Visit.
研究概览
简要总结
One of the greatest success stories in rheumatology - the achievement of rheumatoid arthritis (RA) remission - is tempered by the fact that individuals with RA are dramatically under evaluated and under treated to reduce the risk for heart attacks and strokes. This project will build the foundation for an intervention that will test the hypothesis that the patient-centered intervention tailored to patients with RA to improve hyperlipidemia screening and treatment, thereby decreasing the risk for heart attacks and strokes.
The aims of this proposal are:
Aim 1: To identify patient and physician barriers to lower the risk for heart attacks and strokes in patients with RA.
Aim 2: To develop an intervention designed to optimize lipid screening and management in RA patients. This will consist of patient education and a decision support program to facilitate screening for hyperlipidemia (high cholesterol level) or initiation of medications to lower cholesterol (primary outcome) and self-efficacy (level of confidence in performing a task) in taking medications to lower cholesterol secondary outcome).
Aim 3: To pilot test the efficacy and feasibility of intervention developed in Aim 2. The investigators will apply methods related to clinical trials to test the feasibility of the newly developed intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 40 and 75 years (inclusive)
- •Provide a date of their next appointment with their rheumatologist or other physician on their care team
- •Willing to work with a peer coach
- •Speaks English
- •Have a phone
- •Has access to the internet
- •Resides or lives in the US
排除标准
- •Do not have rheumatoid arthritis
- •Younger than age 40 or older than age 75
- •Taking a statin
- •No known history of diabetes
- •No known history of CVD defined by:
- •Open heart surgery
- •Coronary angioplasty
- •History of heart failure
- •History of heart attack or stroke
研究组 & 干预措施
Peer coach guided online learning program
干预措施: Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis (Behavioral)
Self-administered online learning program
干预措施: Standard of care (Behavioral)
结局指标
主要结局
Number of Subjects With Lipids Checked (Available Now Through National Laboratory Chain) or That Reported Having Their Lipids Checked by Their 1-week or 3-month Visit.
时间窗: 3 months post-intervention, approximately 20 weeks
Self-reported
次要结局
- Change in General Self-Efficacy (GSF) Score From Baseline to the End of the Study Between Arms.(Baseline and 3-months post-intervention, approximately 20 weeks)
- Change in Patient Activation Measure (PAM) Score From Baseline to the End of the Study Between Arms.(Baseline and 3-months post-intervention, approximately 20 weeks)
- Change in Routine Assessment of Patient Index Data (RAPID3) Score From Baseline to the End of the Study Between Arms.(Baseline and 3-months post-intervention, approximately 20 weeks)
- Change in Patient Health Questionnaire - 8 (PHQ-8) Score From Baseline to the End of the Study Between Arms(Baseline and 3-months post-intervention, approximately 20 weeks)
- Change in Medication Understanding and Use Self-Efficacy Scale (MUSE) Score From Baseline to the End of the Study Between Arms.(Baseline and 3-months post-intervention, approximately 20 weeks)
- Change in MOS Social Support Survey Score From Baseline to the End of the Study Between Arms.(Baseline and 3-months post-intervention, approximately 20 weeks)