Clinical trial NCT04477473: Perceived Impact of the COVID-19 Pandemic on Medical Management and Symptoms in a High Risk Group
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pandemic
Vulnerable Subjects
Long-term Non-invasive Ventilation
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population chosen (patients with chronic hypercapnic respiratory failure treated by noninvasive ventilation) is:

* One of the main focuses of interest of our research group, for close to 30 years
* One of our main clinical activities in our outpatient pulmonary division
* An interesting group because, although these subjects must be considered as vulnerable in case of COVID-19, they have - albeit for COPD - a prognosis of several years of survival
* A group for which the findings of our study can be rapidly translated into adapting clinical practice and management
* An interesting group because although they are often very limited in their activities of daily life (ADL), they are also very resilient, with remarkable coping strategies

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Questionnaire
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Centre antituberculeux; Geneva University Hospital
state: Geneva 14
Study officials:
affiliation: University Hospital, Geneva
name: Jean-Paul Janssens, M.D
role: PRINCIPAL_INVESTIGATOR
References: