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.

NCT04677283 | Completed

• 1 other identifier: 2020-A01027-32
• Study Type: observational
• Target: 1,059
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Symptoms Related to Covid-19

Keywords

Covid-19; serology; Reverse Transcriptase PCR

Outcome Measures

Primary Outcomes (1)

• To define positive cases of coronavirus by "Polymerase Chain Reaction" results and symptomatologies

  3 Months

Secondary Outcomes (5)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Two types of population, EHPAD residents identified and EHPAD professionals

You may qualify if:

• / 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.
• / 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.

You may not qualify if:

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

Sponsors & Collaborators

• Gérond'if: lead

Study Sites (1)

Autonomy Department; ARS Île-de-France

Paris, ARS Île-de-France, 75019, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Martine LE NOC - SOUDANI, MD

  Autonomy Department; ARS Île-de-France

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 21, 2020
• Study Start: May 7, 2020
• Primary Completion: December 9, 2020
• Study Completion: July 8, 2021
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

FR (1)