ELECTOR Treat-to-target Via Home-based Disease Activity Monitoring of Patients With Rheumatoid Arthritis: A 6 Months Multicentre, eHealth Randomised, Non-blinded, Parallel-group, Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Average DAS28-CRP over time
研究概览
简要总结
The aim of this study is to explore whether the effectiveness of home-based disease activity monitoring via a home-based (eHealth) intervention is superior to standard clinical disease activity assessment in obtaining and maintaining a low(er) disease activity in patients with rheumatoid arthritis (RA).
详细描述
The aim of RA therapy is to reduce disease activity, joint destruction, symptoms, and disability. The prevailing therapeutic approach is an aggressive pharmacological disease control, with readily available conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) in first line. The csDMARDs goes a long way towards reductions in disease activity, symptoms, and disability. However, if satisfactory disease control is not achieved by csDMARDS, addition of biologic medicines can be necessary.
With the efficacy of all these pharmacological options and the current view on "Treat-to-Target" (T2T), RA patients should have excellent prospects. However, despite the evidence to support a T2T strategy it is anticipated that many patients across various countries in Europe have active disease and suffer from increasing disability; this might be a consequence of bad access to optimal care, as well as possibly a lack of reimbursement of biological agents. Currently, the proposed T2T strategies are managed in the clinic by physicians, nurses and biometricians, which is expensive and time consuming for both patients and health care professionals (HCPs).
Telemonitoring and eHealth solutions for assessing patients with chronic illnesses as diabetes, asthma and hypertension have previously shown great advantages in better disease control and improvement of symptoms. A similar eHealth solution for patients with RA is expected to be advantageous both for patients and the health care system.
The current trial is designed to assess if an eHealth solution for homebased disease activity monitoring is superior to the standard clinical disease monitoring strategy with respect to T2T goals. The main research question is whether the effectiveness of home-based disease activity monitoring via a home-based (eHealth) intervention is superior to standard clinical disease activity assessment in obtaining and maintaining a low(er) disease activity in patients with RA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Patients diagnosed with rheumatoid arthritis
- •Diagnosed with RA > 12 months
- •Age between 18 and 85 years
- •Computer and Internet connection at home and ability to employ these
- •Hand function that allows self-testing of blood test at home.
排除标准
- •Blood samples (creatinine, haemoglobin) outside lower normal limit - 5 % and upper normal limit + 5 % at screening.
- •Blood samples (thrombocytes and leukocytes) outside lower normal limit - 15 % and upper normal limit + 15 % at screening
- •Blood samples (ALT) outside lower normal limit - 100 % and upper normal limit + 100 % at screening
- •Previously diagnosed with neutropenia and/or pancytopenia
- •Dementia or other 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
Average DAS28-CRP over time
时间窗: 6 months from baseline
The Disease Activity Score (DAS) is a combined index that has been developed to measure the disease activity in patients with RA. It is a composite of standard clinical, laboratory data, and patient-reported data. The DAS28-CRP requires a standard blood sample (20 ml) to be drawn and analysed.
次要结局
- The Short Form (36) Health Survey(The SF-36)(Change in the overall scores of the short form 36 questionnaire)
- Swollen-joint count,(6 months from baseline)
- DAS28-CRP<3.2(6 months from baseline)
- Remission(6 months from baseline)
- Erythrocyte sedimentation(6 months from baseline)
- Simplified Disease Activity Index(6 months from baseline)
- Clinical Disease Activity Index(6 months from baseline)
- Rheumatoid Arthritis Impact of Disease (RAID)(6 months from baseline)
- Patient's Global Assessment(6 months from baseline)
- HAQ-DI(6 months from baseline)
- DAS28-CRP<2.6(6 months from baseline)
- Tender-joint count(6 months from baseline)
- Physician's Global Assessment(6 months from baseline)
- Patient's assessment of pain(6 months from baseline)
- High-sensitivity C-reactive protein(6 months from baseline)
- Brief illness perception questionnaire (IPQ-B)(6 months from baseline)
研究者
Henning Bliddal
Head of the Parker Institute
Frederiksberg University Hospital