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临床试验/NCT04390126
NCT04390126已完成不适用

COVID-19 Related Lockdown Effects On Chronic Diseases

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 1,343 人开始时间: 2020年4月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,343
试验地点
1
主要终点
% adherence to each pharmacological class

研究概览

简要总结

The containment associated with the VIDOC-19 pandemic creates an unprecedented societal situation of physical and social isolation. Our hypothesis is that in patients with chronic diseases, confinement leads to changes in health behaviours, adherence to pharmacological treatment, lifestyle rules and increased psychosocial stress with an increased risk of deterioration in their health status in the short, medium and long term.

Some messages about the additional risk/danger associated with taking certain drugs in the event of COVID disease have been widely disseminated in the media since March 17, 2020, the date on which containment began in France. This is the case, for example, for corticosteroids, non-steroidal anti-inflammatory drugs but also for converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists (ARBs2). These four major classes of drugs are widely prescribed in patients with chronic diseases, diseases specifically selected in our study (corticosteroids: haematological malignancies, multiple sclerosis, Horton's disease; ACE inhibitors/ARAs2: heart failure, chronic coronary artery disease). Aspirin used at low doses as an anti-platelet agent in coronary patients as a secondary prophylaxis after a myocardial infarction can be stopped by some patients who consider aspirin to be a non-steroidal anti-inflammatory drug. Discontinuation of this antiplatelet agent, which must be taken for life after an infarction, exposes the patient to a major risk of a new cardiovascular event.

The current difficulty of access to care due to travel restrictions (a theoretical limit in the context of French confinement but a priori very real), the impossibility of consulting overloaded doctors, or the cancellation of medical appointments, medical and surgical procedures due to the reorganization of our hospital and private health system to better manage COVID-19 patients also increases the risk of worsening the health status of chronic patients who by definition require regular medical monitoring.

Eight Burgundian cohorts of patients with chronic diseases (chronic coronary artery disease, heart failure, multiple sclerosis, Horton's disease, AMD, haemopathic malignancy, chronic respiratory failure (idiopathic fibrosis, PAH) haemophilia cohort) will study the health impact of the containment related to the COVID-19 pandemic.

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
9 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with one of the following chronic diseases: chronic coronary syndrome, heart failure, multiple sclerosis, Horton's disease, AMD, malignant haemopathy, chronic respiratory failure (idiopathic fibrosis, PAH, haemophilia) and already registered in one of the 8 Burgundian registries/cohorts.

排除标准

  • deceased patient, patient cannot be reached after >3 telephone calls, patient or caregiver does not speak French to carry out telephone interviews

研究组 & 干预措施

AMD and Macular Edema Cohort

干预措施: questionnaire (Other)

Register of haematological malignancies

干预措施: questionnaire (Other)

Idiopathic Pulmonary Fibrosis and PAH Cohort

干预措施: life questionnaires (Other)

Idiopathic Pulmonary Fibrosis and PAH Cohort

干预措施: questionnaire (Other)

Giant Cell Arteritis Cohort

干预措施: life questionnaires (Other)

Giant Cell Arteritis Cohort

干预措施: questionnaire (Other)

AMD and Macular Edema Cohort

干预措施: life questionnaires (Other)

Hemophilia Cohort

干预措施: life questionnaires (Other)

Hemophilia Cohort

干预措施: questionnaire (Other)

Register of haematological malignancies

干预措施: life questionnaires (Other)

Multiple Sclerosis Cohort

干预措施: life questionnaires (Other)

Multiple Sclerosis Cohort

干预措施: questionnaire (Other)

Myocardial Infarction Observatory RICO

干预措施: life questionnaires (Other)

Myocardial Infarction Observatory RICO

干预措施: questionnaire (Other)

Heart Failure Cohort

干预措施: life questionnaires (Other)

Heart Failure Cohort

干预措施: questionnaire (Other)

结局指标

主要结局

% adherence to each pharmacological class

时间窗: during the period from 20 April 2020 to 7 May 2020

increase in dose, decrease in dose, discontinuation or no change for each drug class)

number of occurrence of medical events at 1 year

时间窗: throughout the study for 12 months

(mortality, hospitalizations and relevant criteria for each pathology all related to the chronic disease)

次要结局

  • Expressed in %: Non-pharmacological treatment/lifestyle:(during the period from 20 April 2020 to 7 May 2020)
  • Expressed in %: Difficulties accessing care: medical appointments, prescriptions, medication(during the period from 20 April 2020 to 7 May 2020)
  • Measurement of psychological distress: Kessler's specific questionnaire (score between 0 and 24)(during the period from 20 April 2020 to 7 May 2020)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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