Perceived Impact of the COVID-19 Pandemic on Medical Management and Symptoms in a High Risk Group

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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COVID-19 Pandemic, Vulnerable Subjects, Long-term Non-invasive Ventilation

Intervention / Treatment
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* Other: Questionnaire-based observational study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients followed by the Division of Pulmonology of Geneva University Hospitals with home NIV Aged above 18 years of age Stable clinical condition Exclusion Criteria: Age below 18 years of age Unwillingness to participate Unstable clinical condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vulnerable subjects<br>Patients under long-term non-invasive ventilation (respiratory support) at home for chronic respiratory failure | Other: Questionnaire-based observational study<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire | 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 | 2 months |