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

NCT04477473 | Completed

• 1 other identifier: 2020-01509
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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

  2 months

Study Arms (1)

Vulnerable subjects

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

Other: Questionnaire-based observational study

Interventions

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)

Vulnerable subjects

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients followed by the Division of Pulmonology of Geneva University Hospitals with home NIV
• Aged above 18 years of age
• Stable clinical condition

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Centre antituberculeux; Geneva University Hospital

Geneva, Geneva 14, 1211, Switzerland

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jean-Paul Janssens, M.D

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 20, 2020
• Study Start: June 30, 2020
• Primary Completion: August 30, 2020
• Study Completion: August 31, 2020
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

CH (1)