COVID-19 PandemicNCT04477473
Perceived Impact of the COVID-19 Pandemic on Medical Management and Symptoms in a High Risk Group
An observational study of COVID-19 Pandemic and Vulnerable Subjects, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19 Pandemic, Vulnerable Subjects, Long-term Non-invasive Ventilation
- What is being tested?
- Questionnaire-based observational study
- How many people
- 66 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jun 2020to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- Patients followed by the Division of Pulmonology of Geneva University Hospitals with home NIV
- Aged above 18 years of age
- Stable clinical condition
Who cannot join
- Age below 18 years of age
- Unwillingness to participate
- Unstable clinical condition
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre antituberculeux; Geneva University Hospital
Geneva, Geneva 14, 1211
About this study
Official 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
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.
- Being tested
- Questionnaire-based observational study
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire-based observational studyOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Vulnerable subjects | Patients under long-term non-invasive ventilation (respiratory support) at home for chronic respiratory failure Receives: Other: Questionnaire-based observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start30 Jun 2020
- Primary completion30 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Paul Janssens, University Hospital, Geneva
- Investigators
- Jean-Paul Janssens, M.D, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477473
- Sponsor's protocol ID
- 2020-01509
- Status last verified
- Oct 2021
- First submitted
- 17 Jul 2020
- Last updated
- 2 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04477473
- Acronym / sponsor ID
- 2020-01509
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vulnerable subjects | – | Other: Questionnaire-based observational studyPatients under long-term non-invasive ventilation (respiratory support) at home for chronic respiratory failure |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Patients followed by the Division of Pulmonology of Geneva University Hospitals with home NIV
- Aged above 18 years of age
- Stable clinical condition
Key exclusion criteria (3 listed)
- Age below 18 years of age
- Unwillingness to participate
- Unstable clinical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire-based observational studyQuestionnaire 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) | Other | Vulnerable subjects |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Paul Janssens, M.D principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pandemic and Vulnerable Subjects, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.