此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia (SePaRIC)

2021年3月29日 更新者:University Hospital, Limoges

Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia Through an Innovative Organizational Strategy

The project proposes to evaluate a strategy for prioritizing teleconsultation for patients with chronic inflammatory rheumatic diseases during the COVID-19 pandemia. This selection will be done through telephone contact by medical students, supervised by residents and rheumatologists on a patient database. The other objectives are to assess the impact of the pandemia on the physical and mental health of patients classified as being at risk

研究概览

详细说明

The COVID-19 pandemic led to the suspension of consultations and hospitalization of the majority of patients followed in the Rheumatology Department of the Limoges University Hospital.

The department therefore implemented a strategy for the management of patients with chronic inflammatory rheumatism (CIR) during this period, which allowed maintaining contact with patients in the patient database.

During this telephone call, an CIR-Covid19 questionnaire was fulfilled in order to prioritize patients requiring rapid management.

The strategy is based on the use of the available health reserve, i.e. volunteered medical students to provide patient management assistance. These students were trained with face-to-face learning in the rheumatology department given by residents on chronic inflammatory rheumatism to remind them of all the elements of diagnosis and management. They had an interview with a senior rheumatologist from the Department to present the questionnaire and its objectives , to give them advice regarding communication with patients, as well as information about the COVID-19 infection and recommendations of the French Rheumatology Society for CIR patients. The students were trained with quizzes on practical situations, with feedback on the answers.

The information's collected in the questionnaire were based on the patients' feelings. Telephone communication does not allow an assessment of disease activity according to validated criteria as it requires a clinical examination.

The opinion of the referring rheumatologist was requested by the patients or by the medical student at the end of the telephone call, depending on the information collected. At any time, the medical students could call upon to senior doctors from the department or residents in case of difficulties.

943 patients were thus contacted between 14/04/2020 and 28/04/2020. They were able to benefit from an optimized management according to the context of the COVID19 pandemic.

These questionnaires were analyze in order to assess the need for specialized follow-up during this period and to evaluate the impact of COVID19 on this population.

研究类型

观察性的

注册 (实际的)

918

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Limoges、法国、87000
        • Service de Rhumatologie, CHu de Limoges

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with chronic inflammatory rheumatism

描述

Inclusion Criteria:

  • Patients with chronic inflammatory rheumatism who answered the RIC-COVID19 survey during the telephone call set up by the Rheumatology Department of the Limoges University Hospital during the confinement.

Exclusion Criteria:

  • Patients objecting to the use of their data

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Proportion of patients requiring an advice from the referring rheumatologist following the telephone survey.
大体时间:2 months
Number of request for advice from the referring Rheumatologist by the student and/or the patient
2 months

次要结果测量

结果测量
措施说明
大体时间
Evaluate the association between rheumatologist advice asked by student and/or patient and the factors studied
大体时间:2 months

Request for an advice from the referring rheumatologist by the student and/or the patient and the factors studied.

Factors studied:

Sex, age, department of residence, RA or AS COVID-19 symptoms, increase in CIR activity, increase in pain, discontinuation of treatment, increase in stress and anxiety, increase in depression, increase in fatigue, increase in sleep disorders, fear of coming to consultation or hospitalization, adaptability with their rheumatic disease, medical loneliness.

2 months
COVID-19 infection evaluation in the monitored patient population
大体时间:2 months
Evaluate the proportion of COVID-19 infection in patients monitored in the Rheumatology department at Limoges University Hospital Proportion of COVID-19 serological tests performed and their positivity in this patient population.
2 months
Proportion of patients informed about COVID-19
大体时间:2 months
Evaluate the proportion of patients having received medical information about the Covid-19 pandemic.
2 months
Evaluate the association between the increase in rheumatic activity perceived by patients and the factors studied
大体时间:2 months
Evaluate the association between the increase in rheumatic activity perceived by patients and the factors studied using numerical scale of satisfaction following this call from patients and students (0-10) 0: unsatisfied, 10 : fully satisfied
2 months
Evaluate the association between pain increase perceived by patients and the factors studied
大体时间:2 months
Percentage increase in pain perceived by patients during the epidemic and factors studied, evaluated by numerical scale during the phone call 0% to 100% (0% represente no pain, and 100% maximal pain)
2 months
Evaluate the association between rheumatologist advice asked by student and the factors studied
大体时间:2 months
request for an advice from the referring rheumatologist by the student and the factors studied
2 months
Evaluate the association between rheumatologist advice asked by patient and the factors studied
大体时间:2 months
request for an advice from the referring rheumatologist by the patient and the factors studied.
2 months
To evaluate the satisfaction of the telephone call with patients and students. Time Frame: phone call day
大体时间:2 months
Numerical scale of satisfaction following this call from patients and students (0-10) 0: unsatisfied, 10 : fully satisfied
2 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Pascale PV Vergne-Salle, MD-PhD、University Hospital, Limoges

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年5月1日

初级完成 (实际的)

2020年7月1日

研究完成 (实际的)

2020年7月31日

研究注册日期

首次提交

2020年12月9日

首先提交符合 QC 标准的

2021年3月18日

首次发布 (实际的)

2021年3月19日

研究记录更新

最后更新发布 (实际的)

2021年4月1日

上次提交的符合 QC 标准的更新

2021年3月29日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅