- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04806867
Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia (SePaRIC)
Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia Through an Innovative Organizational Strategy
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
-
-
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Limoges, Франция, 87000
- Service de Rhumatologie, CHu de Limoges
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of patients requiring an advice from the referring rheumatologist following the telephone survey.
Временное ограничение: 2 months
|
Number of request for advice from the referring Rheumatologist by the student and/or the patient
|
2 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Evaluate the association between rheumatologist advice asked by student and/or patient and the factors studied
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 2 months
|
Numerical scale of satisfaction following this call from patients and students (0-10) 0: unsatisfied, 10 : fully satisfied
|
2 months
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Pascale PV Vergne-Salle, MD-PhD, University Hospital, Limoges
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Коронавирусные инфекции
- Коронавирусные инфекции
- Нидовирусные инфекции
- РНК-вирусные инфекции
- Вирусные заболевания
- Инфекции
- Инфекции дыхательных путей
- Заболевания дыхательных путей
- Пневмония, вирусная
- Пневмония
- Легочные заболевания
- Заболевания суставов
- Заболевания опорно-двигательного аппарата
- Заболевания соединительной ткани
- Бактериальные инфекции
- Бактериальные инфекции и микозы
- Стрептококковые инфекции
- Грамположительные бактериальные инфекции
- Заболевания позвоночника
- Заболевания костей
- Болезни костей, инфекционные
- COVID-19
- Артрит
- Ревматические заболевания
- Коллагеновые заболевания
- Спондилит
- Спондилоартрит
- Ревматическая лихорадка
Другие идентификационные номера исследования
- 87RI20_0044 (SePaRIC)
Планирование данных отдельных участников (IPD)
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Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .