Home Monitoring of Patients With Chronic Diseases - an eRehab Test-retest Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- ADL-Questionnaire: repeated evaluations to adress reliability, validity and responsiveness
研究概览
简要总结
The aim of the study is to establish the intrarater-reliability, criterion validity and responsiveness of the ADL-Questionnaire applied on an eHealth platform to be used by patients diagnosed with rheumatoid arthritis.
The study is designed as a repeated test-retest study including 240 patients filling in the ADL-Q, HAQ-DI and PDQ at day 1, 3, 56 and 58. The study provides an eHealth platform (a home-module in the DANBIO database) which makes it possible for the patients to complete their assessments and send information from their own home.
Intrarater reliability will be assessed by calculating the intraclass correlation coefficients (ICCs). Criterion validity will be evaluated based on correlational analysis and responsiveness based on effect sizes, in both cases involving HAQ-DI. PDQ scores will be used to classify participants based on pain phenotype to explore any relationship between pain phenotype and reliability.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age between 18 and 85 years
- •Computer and Internet connection at home
排除标准
- •Blood samples (creatinine, haemoglobin) outside the reference limits +/- 5 % at screening
- •Blood samples (thrombocytes and leukocytes) outside the reference limit -/+ 15 % at screening
- •Blood samples (ALAT) outside the reference limit -/+ 100 % at screening
- •Dementia or other linguistic/cognitive/physical deficiency that prevents participation
- •Vision impairment that prevents the use of the devices and computer
结局指标
主要结局
ADL-Questionnaire: repeated evaluations to adress reliability, validity and responsiveness
时间窗: Day 1,3,56 and 58
Intrarater reliability: day 1-3 and 56-58. Criterion validity: day 1 Responsiveness: day 1-56
次要结局
- PainDetect Questionnaire (PDQ)(Day 1)
- Standford Health Assessment Questionnaire Disability Index (HAQ-DI)(Day 1 and 56)
研究者
Eva Ejlersen Wæhrens
Senior researcher, PhD
Parker Research Institute