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CompletedNCT04477473Updated Nov 2, 2021

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

An observational study in COVID-19 Pandemic, Vulnerable Subjects and Long-term Non-invasive Ventilation, sponsored by University Hospital, Geneva. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-11-02.

Sponsored by University Hospital, Geneva · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
66
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 66 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
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

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

Exclusion Criteria:

  • Age below 18 years of age
  • Unwillingness to participate
  • Unstable clinical condition
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
66 participants (actual)
Patient registry
No

Groups and cohorts

  • Vulnerable subjects

    Patients under long-term non-invasive ventilation (respiratory support) at home for chronic respiratory failure

    Other: Questionnaire-based observational study

Interventions

  • OtherQuestionnaire-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)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 months

07

Study locations

1 site
  • Centre antituberculeux; Geneva University Hospital
    Geneva, Geneva 14 1211, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04477473
Lead sponsor
University Hospital, Geneva
Responsible party
Jean-Paul Janssens (Professor, University Hospital, Geneva) — Principal investigator
First posted
Jul 20, 2020
Start date
Jun 30, 2020
Primary completion
Aug 30, 2020
Completion
Aug 31, 2020
Last update
Nov 2, 2021

Study contacts

Jean-Paul Janssens, M.D
principal investigator · University Hospital, Geneva

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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