MedDataX Logo

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

NCT ID: NCT04477473

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vulnerable subjects

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

Questionnaire-based observational study

Intervention Type 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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jean-Paul Janssens

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean-Paul Janssens, M.D

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre antituberculeux; Geneva University Hospital

Geneva, Geneva 14, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-01509

Identifier Type: -

Identifier Source: org_study_id