Tight Control of Disease Activity Among Patients With Rheumatoid Arthritis Based on a Systematic Telemedicine Treatment Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Disease Activity Score-CRP (DAS28, CRP)
研究概览
简要总结
The study aims to investigate the effect a systematic telemedicine intervention, based on the tigth control principals, as a platform for disease monitoring among patients with rheumatoid arthritis.
It is hypothesized that:
- A systematic telemedicine intervention targeted to tight control of disease activity among patients with RA will be equally effective as usual care (outpatient consultation by a rheumatologist).
- There will be no difference in the effect whether this telemedicine consultation is carried out by a rheumatologist or a rheumatology nurse.
- Patient satisfaction and the patient's general perception of involvement in their treatment will be increased for patients who receive the telemedicine intervention.
- All the effects will apply both in the short term (< 6 months) and in the long term (> 1 year).
详细描述
Rheumatoid arthritis (RA) is a chronic disease affecting 0.5-1.0 % of the Danish population. Due to an expected growing population and a higher proportion of elderly the prevalence is likely to increase in the years to come.
Untreated RA will lead to joint destruction disabling the patients, but in recent years both treatment and treatment strategies have been markedly improved. According to international guidelines early start of medical treatment, quick escalation of doses, and adjustment of the dose throughout the whole disease course when there are signs of disease activity, are considered important elements in the RA treatment strategy. Consequently, the success of this strategy implies the possibility of regular routine testing of all RA patients, which could become a challenge to the health care system causing substandard treatment to RA patients in the future. This calls for reorganization of the routine care of RA, i.e. in form of a telemedicine intervention.
Telemedicine is considered to be the use of communication and information technologies to deliver clinical care where the individuals involved are not at the same location. No studies have yet investigated the effect of monitoring disease activity through a standardized telemedicine treatment strategy in patients with RA, and most of the evidence is derived from studies within chronic heart disease, chronic obstructive lung disease, asthma, diabetes and hypertension. This evidence indicates, however, that telemedicine interventions seem to be effective, time saving and associated with a high degree of patient satisfaction.
RA disease activity is measured using a composite score that includes both objective and subjective outcome parameters to measure present as well as past disease activity. These scores include: tender and swollen joint count together with the patient's global assessment, report of physical functioning, the measurement of an acute-phase reactant and serial radiographic assessment. The most commonly used instruments for measuring RA disease activity in daily clinical practice is the European League Against Rheumatism (EULAR) criteria, the Disease Activity Score 28 (DAS28).
However, in a telemedicine intervention there is no direct physical contact between the patient and the health professionals, making traditional disease activity measures unfit for use, as they imply an assessment of tender and swollen joints carried out by a health professional. It has been suggested to let the patients examine their joints. Still, it has been shown that patients tend to overestimate the presence of swollen joints which impairs the identification of synovitis - and thereby disease activity and flare. Hence, telemedicine disease activity monitoring in RA may be best supported by validated measures based on other kinds of patient self-assessment, i.e. the newly developed "Flare" instrument.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with rheumatoid arthritis according to the criteria's defined by the American College of Rheumatology, 1987, with a disease duration >= 2 years.
排除标准
- •Patients unable to answer a questionnaire.
结局指标
主要结局
Disease Activity Score-CRP (DAS28, CRP)
时间窗: One year
RA disease activity is measured using DAS28, CRP. This score includes: tender and swollen joint count together with the patient's global assessment, report of physical functioning, the measurement of an acute-phase reactant. The DAS28 score run from 0-9.4 and RA disease activity is defined as followed: DAS28\< 3.2: mild disease activity, DAS28 \>3.2-\< 5.1: moderate disease activity, DAS28 \>5.1: high disease activity.
次要结局
- X Ray, hand and feet(one year)
- Self-efficacy(One year)
