SARS-CoV-2VACOVID-SENIORNCT04779541
National Survey Concerning Vaccination Against COVID-19 in Nursing Homes and Long-Term Care Units
An observational study of SARS-CoV-2 and Covid19, run by University Hospital, Angers at 1 site in France.
Trial summary
The COVID-19 pandemic is a challenge for the French healthcare system, particularly among the elderly due to their particular vulnerability to the serious consequences of the disease, with an estimated mortality rate of around 30-35% among the frail elderly. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- SARS-CoV-2, Covid19
- What is being tested?
- observation
- Type of treatment
- Vaccines
- How many people
- 323 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2021to 29 Sep 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: all french seniors in retirement homes or long-term care units by SARS-CoV-2
Who may be able to join
- People aged 75 years and older in retirement homes or long-term care units who have accepted the SARS CoV-2 vaccine
- People aged 75 years and older in retirement homes or long-term care units who have refused the SARS CoV-2 vaccine
- National survey in france
Who cannot join
- Opposition of the elderly person and/or his or her relatives
Trial locations and contacts
1 site in 1 country.
About this study
The COVID-19 pandemic is a challenge for the French healthcare system, particularly among the elderly due to their particular vulnerability to the serious consequences of the disease, with an estimated mortality rate of around 30-35% among the frail elderly. The management of the health crisis could take a new turn in 2021 with the arrival in France of vaccines against the SARS-CoV-2 virus.
The objectives of this vaccination campaign are to reduce the morbi-mortality attributable to COVID-19 on the one hand, and to maintain essential activities related to the functioning of the country on the other hand and in particular the health system.
Read more
However, the distrust of vaccination, traditionally strong in France, could have a negative impact on this strategy. While the President of the Republic announced on November 24, 2020 that vaccination against SARS-CoV-2 would not be made compulsory, almost one French person in two declared in several surveys that they did not want to be vaccinated; the main criterion for acceptance of vaccination being advanced age (the older they are, the more French people declare accepting to be vaccinated).
In view of the gradual vaccine supply schedule for the year 2021, the French National Authority for Health established at the end of 2020 a prioritization by vaccine availability phases. The critical initial supply phase,which is currently taking place, is the one during which residents of retirement home and long-term care units are prioritized because of their particular vulnerability (age and co-morbidities) and their increased exposure to SARS-CoV-2.
For these reasons, and in order to carry out the current vaccination campaign in the most optimal way possible, this national survey is launching to evaluate the acceptance rate of the SARS-CoV-2 vaccine among people living in retirement homes and long-term care units, to understand the mechanisms of acceptance or rejection, and to draw up an initial large-scale inventory of the symptoms observed following vaccination.
- Conditions
- SARS-CoV-2, Covid19
- Being tested
- observation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
observation of the mechanisms of acceptance or rejection of the vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance rate of the SARS-CoV-2 vaccine among people living in nursing homes and long-term care units
Number of acceptances of the vaccine with analysis of the reason for refusal.
Measured: at baseline
Secondary outcomes (1)
Symptoms related to vaccination against COVID-19
description and identification of symptoms presented after vaccination of elderly patients
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start2 Jun 2021
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779541
- Sponsor's protocol ID
- 2021-028
- Other IDs
- ar21-0004v0
- Acronym
- VACOVID-SENIOR
- Status last verified
- Sep 2021
- First submitted
- 1 Mar 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Survey Concerning Vaccination Against COVID-19 in Nursing Homes and Long-Term Care Units
- ClinicalTrials.gov ID
- NCT04779541
- Acronym / sponsor ID
- VACOVID-SENIOR / 2021-028
- Conditions
- SARS-CoV-2, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 3 Mar 2021 (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 COVID-19 pandemic is a challenge for the French healthcare system, particularly among the elderly due to their particular vulnerability to the serious consequences of the disease, with an estimated mortality rate of around 30-35% among the frail elderly. The management of the health crisis could take a new turn in 2021 with the arrival in France of vaccines against the SARS-CoV-2 virus.
The objectives of this vaccination campaign are to reduce the morbi-mortality attributable to COVID-19 on the one hand, and to maintain essential activities related to the functioning of the country on the other hand and in particular the health system.
However, the distrust of vaccination, traditionally strong in France, could have a negative impact on this strategy. While the President of the Republic announced on November 24, 2020 that vaccination against SARS-CoV-2 would not be made compulsory, almost one French person in two declared in several surveys that they did not want to be vaccinated; the main criterion for acceptance of vaccination being advanced age (the older they are, the more French people declare accepting to be vaccinated).
In view of the gradual vaccine supply schedule for the year 2021, the French National Authority for Health established at the end of 2020 a prioritization by vaccine availability phases. The critical initial supply phase,which is currently taking place, is the one during which residents of retirement home and long-term care units are prioritized because of their particular vulnerability (age and co-morbidities) and their increased exposure to SARS-CoV-2.
For these reasons, and in order to carry out the current vaccination campaign in the most optimal way possible, this national survey is launching to evaluate the acceptance rate of the SARS-CoV-2 vaccine among people living in retirement homes and long-term care units, to understand the mechanisms of acceptance or rejection, and to draw up an initial large-scale inventory of the symptoms observed following vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- all french seniors in retirement homes or long-term care units by SARS-CoV-2
Key inclusion criteria (3 listed)
- People aged 75 years and older in retirement homes or long-term care units who have accepted the SARS CoV-2 vaccine
- People aged 75 years and older in retirement homes or long-term care units who have refused the SARS CoV-2 vaccine
- National survey in france
Key exclusion criteria (1 listed)
- Opposition of the elderly person and/or his or her relatives
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 |
|---|---|---|
| observationobservation of the mechanisms of acceptance or rejection of the vaccine | Other | – |
Primary outcome
Acceptance rate of the SARS-CoV-2 vaccine among people living in nursing homes and long-term care units
Time frame: at baseline
Number of acceptances of the vaccine with analysis of the reason for refusal.
1 secondary outcome
Symptoms related to vaccination against COVID-19
Time frame: at baseline
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 1 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
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 SARS-CoV-2 and Covid19, run by University Hospital, Angers at 1 site in France.
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 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 1 Oct 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 France. 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?
Acceptance rate of the SARS-CoV-2 vaccine among people living in nursing homes and long-term care units (time frame: at baseline). 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 1 Oct 2021.