Developing a Musculoskeletal Ultrasound Program as an Intervention to Improve Disease Modifying Anti-Rheumatic Drugs Adherence in Rheumatoid Arthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Change in proportion of patients with a low adherence score using medication adherence measure (questionnaire)
研究概览
简要总结
Non-adherence to medications can lead to sub-optimal treatment in rheumatoid arthritis (RA) patients. In order to improve disease modifying anti-rheumatic drugs (DMARDs) adherence, the investigators are conducting a randomized controlled trial to test out an intervention to improve medications adherence among low adherers. This intervention involves the use of a musculoskeletal ultrasound program which allows RA patients to visualize their joint inflammation and damage real time while treatment adherence is simultaneously reinforced. In doing so, the investigators hope to improve patients' understanding of their joint disease and motivate the participants to adhere to their medications.
详细描述
This is a single center randomized controlled clinical trial conducted in the Singapore General Hospital. Eligible RA subjects meeting the inclusion and exclusion criteria will be screened using a medication adherence measure questionnaire. Thereafter 132 patients who are low adherers on the questionnaire will then be recruited and randomized (in a 1:1 ratio) to either (a) intervention arm (with musculoskeletal US program) or (b) control arm (without musculoskeletal US program), and followed up over a period of about 6 month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients from 21 to 75 years old
- •Underlying rheumatoid arthritis diagnosed using the 1987 or 2010 RA criteria
- •On at least one of the following DMARDs (Methotrexate, Sulfasalazine, Hydroxychloroquine and/or Leflunomide)
排除标准
- •Pregnancy
结局指标
主要结局
Change in proportion of patients with a low adherence score using medication adherence measure (questionnaire)
时间窗: baseline and 1 month
次要结局
- Change in proportion of patients with a low adherence score using medication adherence measure (questionnaire)(baseline, 3 months and 6 months)
- Change in proportion of patients with a low adherence score using medication adherence measure (pharmacy dispense data)(baseline, 1 month, 3months and 6 months)