A Multicenter, Randomized, Open Study to Evaluate the Impact of an Electronic Data Capture System on the Care of Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,079
- 主要终点
- Primary endpoints for the Health Tracker-user group are the change in the patient satisfaction and patient-physician interaction surveys between the pre- and post-randomization phases.
研究概览
简要总结
The purpose of this study is to evaluate the utility of an electronic data capture system (EDCS) in a rheumatology clinical practice setting and to assess the impact of this system on patient satisfaction with patient-physician interaction.
详细描述
This is a randomized, multicenter observational study to assess the impact of the EDCS in a rheumatology clinical practice setting on patient satisfaction with patient-physician communication using the Health Tracker electronic data capture system . Patients will be randomly assigned in a 2:1 ratio to the Health Tracker-user or non-user groups, respectively. The primary outcomes of this study will be the impact that information gathered and analyzed by an electronic data capture system has on patient satisfaction with arthritis care and patient physician interactions in clinical practice. Patient satisfaction will be assessed using a questionnaire developed specifically for this study.
This study does not involve the use of any investigational drugs, and the protocol does not mandate the treatment regimen patients will receive. Physicians will prescribe antirheumatic medications in accordance with usual clinical practice. The planned duration of subject participation is 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients diagnosed with active rheumatoid arthritis according to the revised criteria of the ACR (1987)
- •Have rheumatoid arthritis that requires regularly scheduled visits with their rheumatologist at least every 3 months
- •Willing and able to adhere to protocol requirements and participate in a study, lasting 12 months
排除标准
- •Patients currently receiving investigational drugs
- •Currently participating in other clinical trials or safety registries for rheumatoid arthritis or rheumatoid arthritis -related therapies
结局指标
主要结局
Primary endpoints for the Health Tracker-user group are the change in the patient satisfaction and patient-physician interaction surveys between the pre- and post-randomization phases.
次要结局
- Changes between the pre- and post-randomization phases in the following clinical evaluations: HAQ scores, SF-12 scores, Patient assessed painful and/or swollen joint counts, Health care professional assessed tender and swollen joint counts