Impact of Capillaroscopy on the Management of Undifferentiated Connective Tissue Disease: a Randomized Pilot Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of participants who transitioned from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease
研究概览
简要总结
Connective tissue diseases (CTD) are a group of diseases with diverse manifestations, most often multisystemic, which share an autoimmune etiology. They include Systemic lupus erythematosus (SLE), Systemic sclerosis (SSc), Sjögren's syndrome (SS), Inflammatory myopathies (IM) and Mixed connective tissue disease (MCTD).
Many patients in rheumatology present signs and symptoms of CTD, but without meeting all the classification criteria for one of these diseases. These patients will generally receive a diagnosis of undifferentiated connective tissue disease (UCTD). It is increasingly suggested that there are two subgroups of patients with UCTD: one which will eventually evolve into a better characterized CTD (approximately 30% of patients at 5 years) and another with a more benign prognosis. The optimal management of patients with UCTD is not clearly established.
Capillaroscopy is a diagnostic test used in the investigation of patients with CTD. It is a low-cost, non-invasive, rapid and specific test in the evaluation of this class of diseases. Its role is now well established in the diagnosis of SSc and in the investigation of Raynaud's phenomenon. In addition, capillaroscopy helps to identify patients suffering from CTD more quickly.
Knowledge about the role of capillaroscopy in UCTD is more limited. It is established that a significant proportion of patients with UCTD present abnormalities on UCTD present non-specific abnormalities and 11% present a scleroderma pattern. In these patients, abnormal capillaroscopy seems to increase the risk of progressing to a better characterized CTD, notably SSc.
However, although capillaroscopy is increasingly used in rheumatology in patients with CTD, more research is needed to clarify the role of this examination in UCTD. First, it is not established whether capillaroscopy should be performed in all patients with UCTD, nor when exactly it should be performed. There also remain questions about the impact of capillaroscopy on the prognosis and management of patients with this disease. To our knowledge, there is no prospective study that has addressed this question. The investigators hypothesize that in patients with UCTD, capillaroscopy compared to usual care makes it possible to increase the proportion of patients obtaining a diagnosis of better characterized CTD in the first six months of follow-up.
详细描述
This is a pilot randomized controlled clinical trial. This monocentric project will be carried out within the rheumatology department of the Quebec university hospital.
The main objective of the project is to determine, in patients with undifferentiated connective tissue disease, to what extent capillaroscopy compared to usual care influences the proportion of patients obtaining a diagnosis of better characterized connective tissue disease in the first six months of follow-up.
The secondary objectives are:
- Determine, in patients with undifferentiated connective tissue disease, to what extent capillaroscopy influences the following factors after capillaroscopy:
- The proportion of patients obtaining a diagnosis of better characterized connective tissue disease at 12 months;
- Medication changes (addition, discontinuation or change in dosage of non-biological disease modifying drugs, biological disease modifying drugs, medications for Raynaud's syndrome and corticosteroids) at 6 and 12 months;
- The number of medical visits in rheumatology, medical visits in specialties other than rheumatology, hospitalizations and emergency medical visits at 6 and 12 months;
- The number of additional examinations (blood samples, radiological examinations or others) carried out which were prescribed by the treating rheumatologist at 6 and 12 months;
- A change in lifestyle habits (smoking, alcohol and drug consumption, physical activity, diet) at 6 and 12 months;
- Patients' quality of life assessed by the health assessment questionnaire, short form survey-36 and Patient-Reported Outcomes Measurement Information System-29 questionnaires at 6 and 12 months;
- Patient acceptability and satisfaction with the intervention under study at 12 months;
- Evaluate the feasibility of recruiting participants in this study (the investigators will measure the number, proportions and rates of patients recruited and retained, as well as the number of individuals screened, eligible and recruited).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Be aged 18 and over;
- •Have been diagnosed with undifferentiated connective tissue disease by a rheumatologist;
- •Meet the preliminary classification criteria for undifferentiated connective tissue disease: present signs and symptoms suggestive of connective tissue disease, but do not meet the criteria for a connective tissue disease and have a positive antinuclear antibody on at least 2 occasions;
- •Have developed the first signs and symptoms of the disease less than 10 years before recruitment.
排除标准
- •In the opinion of the clinician, have a health condition that does not allow a delay of six months before carrying out the capillaroscopy;
- •Have been diagnosed and/or meet the classification criteria for another connective tissue disease (for example, systemic lupus, etc.);
- •Have already performed a capillaroscopy in the past, regardless of the time or the reason;
- •Be unable to consent or respond to questionnaires.
研究组 & 干预措施
Capillaroscopy
In the capillaroscopy group, the capillaroscopy will be performed in the month following recruitment.
干预措施: Nail capillaroscopy (Diagnostic Test)
Control
In the control group, the capillaroscopy will be performed six months (+/- 2 weeks) after recruitment.
干预措施: Nail capillaroscopy (Diagnostic Test)
结局指标
主要结局
Proportion of participants who transitioned from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease
时间窗: 6 months
The primary endpoint of the study will be the proportion of participants who transitioned from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease at 6 months.
次要结局
- Proportion of participants using drugs other than cannabis(6 and 12 months)
- Proportion of participants who went from a diagnosis of undifferentiated connective tissue disease to a diagnosis of better characterized connective tissue disease(12 months)
- Average number of minutes of moderate to high intensity aerobic physical activity performed per week and per participant(6 and 12 months)
- Average score for the eight components of the Short form survey 36 questionnaire(6 and 12 months)
- Proportion of patients with a healthy weight(6 and 12 months)
- Average number of medical visits in specialties other than rheumatology per participant(6 and 12 months)
- Average number of alcohol drinks (standard drinks) consumed per week and per participant(6 and 12 months)
- Proportion of participants using tobacco products other than cigarettes(6 and 12 months)
- Proportion of participants using cannabis products(6 and 12 months)
- Proportion of participants who reported adopting a diet following the healthy eating recommendations of Canada's Food Guide(6 and 12 months)
- Average score on the Health Assessment Questionnaire(6 and 12 months)
- Proportion of participants with a medication change from the baseline visit(6 and 12 months)
- Average number of hospitalizations per participant(6 and 12 months)
- Average number of emergency room visits per participant(6 and 12 months)
- Average number of additional examinations(6 and 12 months)
- Average number of cigarettes smoked per day per participant(6 and 12 months)
- Average number of rheumatology medical visits per participant(6 and 12 months)
- Proportion of patients who are active smokers, former smokers and have never smoked(6 and 12 months)
- Average score on the eight components of the Patient-Reported Outcomes Measurement Information System29 scale(6 and 12 months)