Cell Phone Based Automated Monitoring of Patients With Early Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medcare Oy
- 入组人数
- 165
- 试验地点
- 4
- 主要终点
- remission
研究概览
简要总结
The purpose of this study is to determine whether automated remote monitoring of patients with early rheumatoid arthritis by the SandRA software and short message service of cell phones increases patient compliance and helps to identify patients needing re-assessment of medication before scheduled visits. This might result in better clinical outcome and cost-effectiveness.
详细描述
To improve monitoring of patients with early RA the investigators have developed an automated remote monitoring system SandRA (Showing-any-need-for-Re-Assessment) based on short message service (SMS) of cell phones and patients' global assessment of the severity of RA (PtGA) on a numeric scale of 0 to 10.
SandRA software sends every 2 to 6 weeks automatically an SMS to a patient's cell phone, and the patient answers by one push on keyboard. The patients' answers are recorded in SandRA and automatically analysed. If answers indicate non-adherence, adverse events, or missed target, the system automatically sends SMS: "Your nurse will call you within 2 work days", and the nurse gets an alarm by e-mail. If needed, an extra visit is arranged for treatment adjustment.
Preliminary studies show that PtGA given by cell phone has sufficient convergent validity. Structured feedback from patients has been favourable and most professionals assess the system as feasible.
The objective of this study is to investigate the impact of SandRA monitoring on clinical outcomes of RA, on patients' quality of life and drug adherence, as well as consumed resources. Cost-effectiveness of SandRa is estimated.
Methods Consecutive incident patients (200) with RA are enrolled. Those, who can use SMS messages of cell phone, who understand the SandRA system, and are willing, are included. After informed consent the patients are randomized into two groups: 1) SandRA group and 2) control group.
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
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfillment of the EULAR 2010 classification criteria for rheumatoid arthritis
- •Commencement of the first anti rheumatic medication
- •Ability to use short message service of cell phones,
- •Comprehension of the function of the SandRA monitoring system
- •Willingness to participate.
排除标准
- •Failure to fulfill the inclusion criteria.
研究组 & 干预措施
SandRA
cell phone monitoring
干预措施: SandRA (Procedure)
Control
conventional monitoring
结局指标
主要结局
remission
时间窗: at 6 months (co-primary 12 months)
number of remissions at each arm, defined by no tender or swollen joints (44 joints) and normal CRP
次要结局
- patient confidence(at 0, 3, and 6 months)
- quality of life(at 0, 3, and 6 months)
- drug adherence(during 6 months)
- consumption of resources(during 6 months)