Quality of LifeVIDI-CAPNCT05408286
Post Covid-19 Quality of Life After Hospital Discharge in Patients Treated With NIV/C-PAP
An observational study of Quality of Life, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial summary
A multicenter longitudinal study with data collection at 4 and 8 months after hospital discharge. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- administration of questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 145 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2020to 30 Jun 2021
- 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 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consisted of patients treated with NIV/CPAP, admitted to the COVID-19 wards of the AO SS Antonio e Biagio and Cesare Arrigo in Alessandria (the promoting center), the Azienda Sanitaria Locale Bt (Barletta, Andria, Trani) and the Azienda Socio Sanitaria Territoriale in Lecco, from November 2020 to June 2021
Who may be able to join
- All patients aged ≥18 years admitted for COVID-19 pneumonia treated with NIV/CPAP, discharged to their home with a negative molecular swab and signed informed consent were included in the study
Who cannot join
- Exclusion criteria were set in; patients admitted for COVID-19 pneumonia treated with NIV/CPAP and invasive ventilation and patients with pre-existing cognitive disorders at the hospital admission date.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda ospedaliera nazionale SS Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
About this study
Official title: Impact of COVID-19 on Quality of Life After Hospital Discharge in Patients Treated With NIV/C-PAP: an Observational, Prospective Multicenter Study.
A multicenter longitudinal study with data collection at 4 and 8 months after hospital discharge.
Read the detailed description
The study population consisted of patients treated with NIV/CPAP, admitted to the COVID-19 wards of the AO SS Antonio e Biagio and Cesare Arrigo in Alessandria (the promoting center), the Azienda Sanitaria Locale Bt (Barletta, Andria, Trani) and the Azienda Socio Sanitaria Territoriale in Lecco, from November 2020 to June 2021. The study assessed at 4 and 8 months after hospital discharge in the patient's home environment, quality of life, residual disability, anxiety and insomnia.
Enrollment took place only after the approval of the Ethics Committee of each participating center.
- Conditions
- Quality of Life
- Being tested
- administration of questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of questionnairesBehavioural
administration of questionnaires
| Study group | Role | What they receive |
|---|---|---|
| inclusion criteria | All patients aged ≥18 years admitted for COVID-19 pneumonia treated with NIV/CPAP, discharged to their home with a negative molecular swab and signed informed consent were included in the study. Receives: Behavioral: administration of questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 qualità di vita
polmonite COVID-19 qualità di vita
Measured: 8 mesi
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Nov 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bertolotti Marinella, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Investigators
- Tatiana Bolgeo, PhD, Principal investigator, Azienda Ospedaliera nazionale SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy, EU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408286
- Sponsor's protocol ID
- VIDI
- Acronym
- VIDI-CAP
- Status last verified
- Jun 2022
- First submitted
- 4 Mar 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 on Quality of Life After Hospital Discharge in Patients Treated With NIV/C-PAP: an Observational, Prospective Multicenter Study.
- ClinicalTrials.gov ID
- NCT05408286
- Acronym / sponsor ID
- VIDI-CAP / VIDI
- Conditions
- Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 7 Jun 2022 (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.
A multicenter longitudinal study with data collection at 4 and 8 months after hospital discharge.
Detailed description
The study population consisted of patients treated with NIV/CPAP, admitted to the COVID-19 wards of the AO SS Antonio e Biagio and Cesare Arrigo in Alessandria (the promoting center), the Azienda Sanitaria Locale Bt (Barletta, Andria, Trani) and the Azienda Socio Sanitaria Territoriale in Lecco, from November 2020 to June 2021. The study assessed at 4 and 8 months after hospital discharge in the patient's home environment, quality of life, residual disability, anxiety and insomnia.
Enrollment took place only after the approval of the Ethics Committee of each participating center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inclusion criteria | – | Behavioral: administration of questionnairesAll patients aged ≥18 years admitted for COVID-19 pneumonia treated with NIV/CPAP, discharged to their home with a negative molecular swab and signed informed consent were included in the study. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of patients treated with NIV/CPAP, admitted to the COVID-19 wards of the AO SS Antonio e Biagio and Cesare Arrigo in Alessandria (the promoting center), the Azienda Sanitaria Locale Bt (Barletta, Andria, Trani) and the Azienda Socio Sanitaria Territoriale in Lecco, from November 2020 to June 2021
Key inclusion criteria (1 listed)
- All patients aged ≥18 years admitted for COVID-19 pneumonia treated with NIV/CPAP, discharged to their home with a negative molecular swab and signed informed consent were included in the study
Key exclusion criteria (1 listed)
- Exclusion criteria were set in; patients admitted for COVID-19 pneumonia treated with NIV/CPAP and invasive ventilation and patients with pre-existing cognitive disorders at the hospital admission date.
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 |
|---|---|---|
| administration of questionnairesadministration of questionnaires | Behavioural | inclusion criteria |
Primary outcome
COVID-19 qualità di vita
Time frame: 8 mesi
polmonite COVID-19 qualità di vita
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 7 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Tatiana Bolgeo, PhD principal investigator
Azienda Ospedaliera nazionale SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy, EU
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 Quality of Life, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
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 1 inclusion and 1 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 7 Jun 2022. 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 Italy. 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?
COVID-19 qualità di vita (time frame: 8 mesi). 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 7 Jun 2022.