Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Intrarater reliability of DAS28 done by patients
研究概览
简要总结
A two-step multi-centre study with 240 rheumatoid arthritis patients.
详细描述
A two-step multi-centre study containing:
A test-retest study including 180 patients filling in questionnaires and performing joint assessments to assess reliability of patient generated data
AND
An agreement study focusing on questionnaires and joint assessments performed by 60 patients, a medical student, a physician and by an ultrasound-examinator assessing agreement between the four assessors
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with RA ≥ 12 months
- •DAS28-CRP < 5,1
排除标准
- •Dementia or other linguistic/cognitive/physical deficiency that prevents participation
- •Vision impairment that prevents the use of the devices and computer
研究组 & 干预措施
online instruction at followup visits
patients in this group will be subjected to view video instructions online prior to performing the follow-up joint scoring at home
干预措施: instruction (Other)
standard baseline instruction
after the initial training patients in this group will not be subjected to any subsequent instructions prior to performing the follow-up joint scoring at home
干预措施: standard baseline instruction (Other)
结局指标
主要结局
Intrarater reliability of DAS28 done by patients
时间窗: Baseline
次要结局
- Inter- and intrarater realiabilty of DAS38(8 weeks)
- Intrarater reliability of joints counts performed by patients(Baseline)
- Intrarater reliability of joint scores performed by patients(8 weeks)
- Interrater agreement of DAS28CRP(Baseline)
研究者
Henrik Gudbergsen
EU project coordinator
Parker Research Institute