Study of Symptoms Linked to Covid-19 in Residents and Professionals in EHPAD, Associated With a Dual Diagnostic Approach by PCR and Serology: a Cohort in Île-de-France. (COVID - EHPAD)

The main purpose is to study the prevalence of Covid-19 in EHPAD. The primary endpoint will be the combination of PCR results and symptomatology, making it possible to define positive cases in EHPAD, in residents and professionals in contact with them. The prevalence obtained can be compared with the results of serology if these are performed.

Study Overview

• Status: Completed
• Conditions: Symptoms Related to Covid-19

Detailed Description

This study is taking place in several nursing homes in Ile-de-France, which will be recruited at the end of the diagnostic campaign.

At the initiative of the ARS Ile-de-France, residents and professionals of selected EHPADs will be subjected to systematic screening by RT-PCR for Covid-19, then by serology after the first screening, regardless of whether either the result

Samples, by nasopharyngeal swab for RT-PCR, by capillary blood sampling or venipuncture according to the technique for serology, will be carried out according to the doctrines issued by the ARS Ile de France and the variations proposed by the appropriate departmental directorates in depending on local resources. The results will be brought to the attention of EHPADs to adapt the care of residents and positive professionals.

Data will be collected daily from collection for the first test (RT-PCR), or retrospectively if the collection took place before the study.

Regarding the approach for collecting serologies:

• All subjects included with a negative PCR will be offered the serological test, in accordance with the recommendations in force or the medical decisions of the establishments.
• The qualitative results of the serologies of the subjects included in the study (residents and professionals) will be collected according to the same circuit as those of the RT-PCRs.
• Only the symptoms of residents with a positive serology will be collected, from the date of the sample and for a period of 14 days.
• The symptoms of professionals with a positive serology can be collected, from the date of the sample and for a period of 14 days without mandatory character.
• Both techniques (ELISA or TROD) are accepted and the serology values will not be collected.

• Study Type: Observational
• Enrollment (Actual): 1059

Contacts and Locations

Study Locations

• France
  • ARS Île-de-France
    • Paris, ARS Île-de-France, France, 75019
      • Autonomy Department; ARS Île-de-France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Two types of population, EHPAD residents identified and EHPAD professionals

Description

Inclusion Criteria:

1. / Residents of nursing homes in Île-de-France in which systematic Covid-19 screening tests were carried out and agreeing to participate in the study.
2. / Professionals in nursing homes in Île-de-France in which systematic screening tests for Covid-19 were carried out and agreeing to participate in the study: nursing assistants, nurses, coordinating doctors, hotel and service agents hygiene, etc.

Exclusion Criteria:

1. / Expression of opposition to the collection of symptoms by professionals, residents or their legal representatives.
2. / Subjects who have not had a diagnostic test by RT-PCR.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To define positive cases of coronavirus by "Polymerase Chain Reaction" results and symptomatologies	3 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of commorbidity risk according Charlson score	3 Months
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale	3 Months
Assessment of teh degree of autonomy according AGGIR score	3 Months
Measuring cognitive impairment according Mini-Mental State Examination (MMSE) scores	3 Months
Screening for a nutritional disorder according Body Mass Index (BMI) score	3 Months

Collaborators and Investigators

• Sponsor: Gérond'if
• Investigators: Study Chair: Martine LE NOC - SOUDANI, MD, Autonomy Department; ARS Île-de-France

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2020
• Primary Completion (ACTUAL): December 9, 2020
• Study Completion (ACTUAL): July 8, 2021

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (ACTUAL): December 21, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Covid-19; serology; Reverse Transcriptase PCR
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020-A01027-32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No