A Lifestyle Intervention for Rheumatoid Arthritis: Effect of an Intensive Therapeutic Lifestyle Change Program on Inflammatory Markers and Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Change in HAQ-2 score
研究概览
简要总结
The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis.
详细描述
The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis. If a lifestyle intervention is effective, we expect to see improvement in functional status and decreased health care costs to the study participant and the insurer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •BCBSVT members who also carry the prescription benefit with BCBSVT (due to the need for tracking prescription costs).
- •BCBSVT membership for minimum of 12 months prior to start of study (due to the need for tracking prescription costs before and after intervention).
- •Age 18 or older
- •Medical diagnosis of RA
排除标准
- •Currently taking warfarin (since fluctuating amounts of green leafy vegetable intake can adversely affect INR levels and because we will be asking participants to increase the amount of green leafy vegetables they consume)
- •Malignancy currently undergoing treatment (with further planned treatment at the time of enrollment) since patients undergoing cancer treatment often need to stop RA medications in order to improve immune function, and thus could be a confounder.
- •Food allergy (including reactions such as hives, wheezing, difficulty breathing, fainting, or anaphylaxis)
研究组 & 干预措施
experimental
standard of care + lifestyle intervention
干预措施: Intensive Lifestyle intervention (Behavioral)
control
no intervention (control group)
结局指标
主要结局
Change in HAQ-2 score
时间窗: Up to 24 months
The HAQ-II is a validated and reliable tool used frequently by rheumatologists evaluating patients with RA (Wolfe et al, 2004). It is an indicator of quality of life as well as functional status. It is also a predictor of premature mortality.
Change in serum C-Reactive Protein
时间窗: Up to 24 months
CRP is a reliable marker of acute and chronic inflammation (Sproston and Ashworth, 2018).
次要结局
- Change in dosage of RA-related medications(Up to 24 months)
- Change in blood pressure(Up to 24 months)
- Change in weight(Up to 24 months)
- Change in serum LDL cholesterol(Up to 24 months)
- Change in serum HbA1c(Up to 24 months)
- Change in RA-related costs for the study participant(Up to 24 months)
- Change in RA-related costs to the insurer(Up to 24 months)
- Change in the number of medications required to treat RA(Up to 24 months)
- Change in serum total cholesterol(Up to 24 months)
- Change in BMI(Up to 24 months)