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

Completed
Conditions
Vulnerable Subjects
COVID-19 Pandemic
Long-term Non-invasive Ventilation
Interventions
Other: Questionnaire-based observational study
Registration Number
NCT04477473
Lead Sponsor
University Hospital, Geneva
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
66
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Vulnerable subjectsQuestionnaire-based observational studyPatients under long-term non-invasive ventilation (respiratory support) at home for chronic respiratory failure
Primary Outcome Measures
NameTimeMethod
Questionnaire2 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Centre antituberculeux; Geneva University Hospital

🇨🇭

Geneva, Geneva 14, Switzerland

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