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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Pandemic; Long-term Non-invasive Ventilation; Vulnerable Subjects
• Intervention / Treatment: Other: Questionnaire-based observational study

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.

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Switzerland
  • Geneva 14
    • Geneva, Geneva 14, Switzerland, 1211
      • Centre antituberculeux; Geneva University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vulnerable subjects; Patients under long-term non-invasive ventilation (respiratory support) at home for chronic respiratory failure	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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Jean-Paul Janssens, M.D, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Actual): August 30, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 31, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020-01509

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No