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

COVID-19 Pandemic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04477473
• Other study ID #: 2020-01509
• Status: Completed
• Start date: June 30, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: October 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 31, 2020
• Est. primary completion date: August 30, 2020
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• Long-term Non-invasive Ventilation
• Vulnerable Subjects

Intervention

Other:
• Questionnaire-based observational study
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)

Locations

Country	Name	City	State
Switzerland	Centre antituberculeux; Geneva University Hospital	Geneva	Geneva 14

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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