Prevent and Control COVID-19 Infection in Nursing Homes on the Risk of Death of Residents

NCT04740658 | Completed

• 1 other identifier: RC31/20/0300
• Study Type: observational
• Target: 12,166
• Locations: 1 country
• Sites: 1

Brief Summary

The COVID epidemic has shown very high mortality among older people, especially among poly-morbid and dependent subjects. In addition to the classic risk factors of age, dependence and associated co-morbidities, community life exposes to specific increased risks in the event of this easily inter human transmissible viral epidemic. In France, according to the Direction of research, studies, evaluation and statistics (DREES) data (Ehpa study, 2015) more than 600,000 elderly people currently live in nursing homes (NH). Since March 28, a national guidance for monitoring the COVID epidemic in NH has just been set up. In France, 14 178 of the 29 319 COVID deaths (48.35%) by June 10th 2020 occurred among NHs residents. Work to consolidate these data is underway, suggesting a much heavier balance sheet. Faced to this threat, in addition to practical recommendations (barrier protection gestures), strict instructions were also announced to all NH to keep their residents safe from COVID : restricting all visitors, all volunteers and nonessential personnel, and more recently, confining residents in their room in case of incident case of COVID in the NH. Organizational factors of NH such as the prevention strategies deployed before and during the epidemic (pneumococcal vaccination, restricting group activities), as well as NH internal resources (equipment, nursing staff) and health resources in the NH environment (hospital partnerships, support devices, telemedicine) lead to heterogeneous situations and could influence the death rates of residents. On the other hand, social isolation can also precipitate the decline of fragile residents. Beyond the immediate and directly risks linked to COVID-19, the present hypothesize that the organizational measures (guidance and recommendations) put in place can have, during and at a distance from the outbreak, beneficial effects but also deleterious effects depending on the severity of the outbreak of a geographic area. More precisely, the hypothesis is that strong and well-followed recommendations at the time of the epidemic were associated with a reduction in the risk of total death in particular of deaths related to COVID in the zones most affected by the epidemic but also that strong and well-followed recommendations were associated with an increased risk of total death, in particular of deaths unrelated to COVID in the areas least affected by the epidemic.

Conditions

Covid19

Keywords

epidemic period; nursing homes; mortality; restriction measures impact; beneficial effects; deleterious effects

Outcome Measures

Primary Outcomes (1)

• Death occurrence within one year of follow up

  * Primary criteria is death occurrence within one year of follow up: death rates will be recorded. * Level of implementation of the recommendation/guidance to prevent and control COVID-19 NH residents' infection will be score 14 days before the peak wave of the outbreak in the geographic area of each NH.

  from January 2020 to December 2020

Secondary Outcomes (1)

• deaths related to COVID during the one-year follow-up

  from January 2020 to December 2020

Other Outcomes (4)

• deaths not related to COVID during the one-year follow-up

  from January 2020 to December 2020

• evaluate the economic impact of the implementation of prevention measures

  6 and 12 months before and after the implementation of the preventive measures

• Health economic study: evaluate Direct medical and non-medical costs

  6 and 12 months before and after the implementation of the preventive measures

Interventions

No intervention OTHER

There is no intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NH volunteers located in different regions more or less affected by the epidemic and NH coordinating physician/directors of NHs via the SFGG website, directors of large private groups (Korian, Orpea, Edenis, DOMUS-vi ..) or public groups (APHP), regional (FMC Gériatres 31) and national (FFAMCO) NH coordinating physician associations (FFAMCO, MCOOR), the referents geriatricians of large cities that have been particularly exposed to the epidemic (Mulhouse, Strasbourg, Paris) or particularly least exposed (Bordeaux, Brest).

You may qualify if:

• Within each NH, all NH residents living in the NH the 1st of January 2020 will be included.

You may not qualify if:

• NHs or Long Term Care Facilities (LTCFs) that refuse to participate.
• NHs that are not voluntary or not located in the regions and NHs that do not have a coordinating doctor .
• Within each NH, all NH residents not living in the NH or LTCFs the 1st of January 2020 will be not be included.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse - Gérontopôle

Toulouse, 31059, France

Location

Related Publications (1)

• Rolland Y, Pennetier D, Shourick J, Barreto PS, Mathieu C, Blain H, Balandier C, Bonin-Guillaume S, Durel G, Gavazzi G, Guion V, Guerin O, Hanon O, Jeandel C, Jouatel L, Maubourguet N, Orvoen G, Passadori Y, Renoux A, Roubaud-Baudron C, Roussillon Soyer C, Salles N, Tabue-Teguo M, Villars H, Andrieu S. Association between strategies to prevent COVID-19 infection in long-term care facilities and mortality: the PIANO-COVID-19 study, a French multicentre cohort study. BMJ Public Health. 2025 Jun 20;3(1):e002156. doi: 10.1136/bmjph-2024-002156. eCollection 2025.

  PMID: 40551971 RESULT

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

• Yves ROLLAND, MD, PHD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 5, 2021
• Study Start: July 8, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (1)