National Survey Concerning Vaccination Against COVID-19 in Nursing Homes and Long-Term Care Units

Covid19 Clinical Trial

— VACOVID-SENIOR  

Official title:

National Survey Concerning Vaccination Against COVID-19 in Nursing Homes and Long-Term Care Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04779541
• Other study ID #: 2021-028
• Secondary ID: ar21-0004v0
• Status: Completed
• Start date: June 2, 2021
• Est. completion date: September 29, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: September 29, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Opposition of the elderly person and/or his or her relatives

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV-2

Intervention

Other:
• observation
observation of the mechanisms of acceptance or rejection of the vaccine

Locations

Country	Name	City	State
France	Angers University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at baseline
Secondary	Symptoms related to vaccination against COVID-19	description and identification of symptoms presented after vaccination of elderly patients	at baseline