Rheum@Home: Rheumatoid Arthritis Care in the 21th Century
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of rheumatology outpatient visits with rheumatologists and nurses
研究概览
简要总结
The goal of this pragmatic multicentre clinical trial is to investigate whether telemonitoring with Rheum@Home leads to less outpatient visits, while maintaining tight disease control and high patient-experienced quality of care in patients with rheumatoid arthritis.
Participants will be asked to
- complete questionaires every 4 weeks
- perform a walking test every 4 weeks
- routine lab
- routine disease activity measurement by a qualified assessor
Researchers will compare care via the telemedicine system (intervention) or standard care (control) to see if there are differences in the number of rheumatology outpatient visits and patient reported quality of care after 12 months follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all consecutive patients;
- •signed, written informed consent;
- •18 -75 years of age;
- •clinical diagnosis of RA;
- •≥ 6 months stable low disease activity or remission, according to the treating rheumatologist;
- •able to read and understand simple Dutch language instructions;
- •ownership or access to a smartphone, tablet or computer and having internet access;
- •able to conduct a teleconsultation on a smartphone, tablet or computer.
排除标准
- •severe comorbidity or other factors necessitating continuation of regular outpatient visits, according to the treating rheumatologist
研究组 & 干预措施
Care via the telemedicine system
Intervention
干预措施: care via the telemedicine system (Other)
Standard care
Control
干预措施: Routine care (Other)
结局指标
主要结局
Number of rheumatology outpatient visits with rheumatologists and nurses
时间窗: 12 month period
Number of rheumatology outpatient visits with rheumatologists and nurses
Patient-reported quality of care
时间窗: 12 month period
measured with visual analogue scale (VAS) scores (0-10; higher score indicates higher quality) in seven relevant domains: patients' satisfaction with health care, patients' experiences contacting their health-care providers, the extent to which health care meets patients' expectations, healthcare workers' timeliness of response to questions and symptoms, health-care workers' fulfilment of agreements, health-care workers attentiveness to acute situations, and hospital accessibility in case of symptoms. A mean score of 8 out of 10 or higher was predefined as perceived high quality
次要结局
- Physical performance: 50 meter walking test(12 month period)
- Number of rheumatology teleconsultations (email, telephone, video)(12 month period)
- DAS28(12 month period)
- PROMs: disease activity score (RAPID3)(12 month period)
- PROMs: Patient acceptable symptom state (PASS)(12 month period)
- PROMs: participation (WPAI)(12 month period)
- PROMs: pain (NRS)(12 month period)
- PROMs: fatigue (NRS)(12 month period)
- PROMs: physical function (HAQ-DI)(12 month period)
- PROMs: health related quality of life (EQ5D)(12 month period)
- PROMs: health related quality of life (SF36)(12 month period)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(12 month period)
- Cost-effectiveness: healthcare utilization questionnaire(12 month period)
- Patient experience: System usability scale (SUS)(12 month period)
- Patient experience: Perceived efficacy in patient-physician interactions (PEPPI-5)(12 month period)
研究者
Harald E. Vonkeman
Principle Investigator
Medisch Spectrum Twente