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OpenTrials
Completed

NCT Number: NCT04477473

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre antituberculeux; Geneva University Hospital

Geneva, Geneva 14, 1211, Switzerland

About this 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.

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire-based observational study

Other

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)

Primary outcomes

  1. Questionnaire

    Time frame: 2 months

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 20, 2020
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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