Perceived Impact of the COVID-19 Pandemic on Medical Management and Symptoms in a High Risk Group: Patients Under Long Term Noninvasive Ventilation for Chronic Hypercapnic Respiratory Failure in Geneva. An Observational Monocentric Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Questionnaire
研究概览
简要总结
The Swiss population underwent a period of confinement related to the COVID-19 pandemic (March 16 to May 11, 2020) decided by the Swiss Federal Government. Among the Swiss population, certain groups were identified as vulnerable subjects by the Federal Office of Public Health. This study focuses on the perceived impact of this period on health care and health status in a specific vulnerable group: patients under long term noninvasive ventilation (respiratory support) at home for chronic respiratory failure.
详细描述
The Swiss population underwent a period of confinement related to the COVID-19 pandemic (March 16 to May 11, 2020) decided by the Swiss Federal Government. Among the Swiss population, certain groups were identified as vulnerable subjects by the Federal Office of Public Health. This study focuses on the perceived impact of this period on health care and health status in a specific vulnerable group: patients under long term noninvasive ventilation (respiratory support) at home for chronic respiratory failure.
The objective is to determine, in a specific vulnerable group, how the confinement related to the COVID-19 pandemic affected health care and health status, as perceived by the patients.
The primary outcome is a questionnaire focusing on practical health care issues regarding respiratory support, health status and perception of the COVID-19 issue:
- Symptom score (related to noninvasive ventilation: NIV)
- Thymic disturbances (score of anxiety and depression)
- Compliance to treatment (assessed via tele-monitoring: routine procedure)
It is a non-interventional questionnaire-based observational study of patients followed by the Division of Pulmonology of Geneva University Hospitals with home NIV, aged above 18 years of age and in a stable clinical condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients followed by the Division of Pulmonology of Geneva University Hospitals with home NIV
- •Aged above 18 years of age
- •Stable clinical condition
排除标准
- •Age below 18 years of age
- •Unwillingness to participate
- •Unstable clinical condition
结局指标
主要结局
Questionnaire
时间窗: 2 months
Questionnaire focusing on practical health care issues regarding respiratory support, health status and perception of the COVID-19 issue: * Symptom score (related to noninvasive ventilation: NIV): S3-NIV (non-invasive ventilation), score ranging from 0 to 10, the lowest possible score (0) corresponds to the highest impact of disease and treatment, the highest possible score (10) corresponds to the lowest impact of disease and treatment. * Thymic disturbances (score of anxiety and depression): HADS (Hospital Anxiety and Depression Scale), score ranging from 0 to 21, 0-7 = normal, 8-10 borderline abnormal, 11-21 =abnormal * COVID confinement questionnaire: de novo questionnaire, Minimal Clinically Important Differences (MCID) unknown
次要结局
未报告次要终点
研究者
Jean-Paul Janssens
Professor
University Hospital, Geneva
