Severe Acute Respiratory Syndrome-Coronavirus-2 and Loss of Autonomy in the Elderly (CovAged)

Impact of SARS-CoV-2 Infection in a Population Aged 70 Years or Older on Loss of Autonomy

In most diseases, older people have less typical symptomatology than that described for younger people. The investigators therefore hypothesize that within the framework of coronavirus disease 19, the clinical pictures in the elderly will present specificities that will need to be described. Moreover, since infection by the severe acute respiratory syndrome (SARS-CoV-2) virus is new to humans, the investigators do not yet have sufficient information on the fate of the elderly, in terms of loss of autonomy, rehospitalization, institutionalization, mortality, etc. the investigators therefore assume that the clinical pictures in the elderly will present specificities that will need to be described. The investigators hypothesize that an acute infection of this type will have short-, medium-, and long-term repercussions in the elderly.

Study Overview

Status

Terminated

Conditions

Detailed Description

The question of the outcome of elderly populations in the immediate aftermath of the epidemic and at a distance from it are essential to measure the effectiveness of the medical care that has been undertaken, but also to adapt the response to the specific problems of the elderly population. It is likely that the older, more fragile population will take longer to recover from the epidemic than the younger population because their functional reserves prior to coronavirus disease 19 are lower. In addition, the possible consequences of containment must be added to the burden of co-morbidities and dependence prior to the epidemic. Containment is synonymous with a restriction in social relationship, and sometimes a reduction in the support provided on a daily basis to frail or even dependent elderly people. Moreover, containment alone may be responsible for the onset or worsening of pathologies.

In most diseases, older people have less typical symptomatology than that described for younger people. The investigators therefore hypothesize that within the framework of coronavirus disease 19, the clinical pictures in the elderly will present specificities that will need to be described. Moreover, since infection by the SARS-CoV-2 virus is new to humans, the investigators do not yet have sufficient information on the fate of the elderly, in terms of loss of autonomy, rehospitalization, institutionalization, mortality, etc. The investigators therefore assume that the clinical pictures in the elderly will present specificities that will need to be described. The investigators hypothesize that an acute infection of this type will have short-, medium-, and long-term repercussions in the elderly.

Study Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Rennes, France, 35000
        • University Hospital of Rennes
      • Tourcoing, France, 59200
        • Va de Lys-Ramsay Gds group Clinic
      • Valenciennes, France, 59300
        • Hopsital of Valenciennes
      • Les Abymes, Guadeloupe, 97139
        • University Hospital of Guadeloupe
      • Fort-de-France, Martinique, 97261
        • University Hospital of Martinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

A cohort of covid-19 patients aged 70 years or older, admitted in a short stay or a rehabilitation geriatric wards.

Description

Inclusion Criteria:

  • 70 years of age or older;
  • Hospitalized in a short stay or a rehabilitation geriatric wards at one of the participating centers;
  • Positive by Reverse Transcriptase-Polymerase Chain Reaction for severe acute respiratory syndrome (SARS-CoV-2) coronavirus or be considered to have SARS-CoV-2 coronavirus based on lung CT data and physician opinion;
  • Formal consent to answer the questionnaire or, in the event of inability to give consent, consent obtained from the trusted third party;
  • Affiliation to a social security scheme.

Exclusion Criteria:

  • Patient under formal guardianship or trusteeship.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loss of autonomy
Time Frame: 36 months
Loss of autonomy (based on the variation of activity of daily living and instrumental activities of daily living score, and new formal or informal help)
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital readmission
Time Frame: 1 month follow-up
Any new hospitalization not scheduled during follow-up. We we will also study early re-hospitalizations (occurring within 30 days or less).
1 month follow-up
Nursing home admission
Time Frame: 36 months
for non-institutionalized persons at inclusion) by a change of residence, from the usual place of residence to a lodging establishment for people dependent elderly, or to a long-term care unit
36 months
All-cause mortality
Time Frame: Inclusion and 36 months
Death considered will be those occurring between inclusion and the end of follow-up
Inclusion and 36 months
change in self-rated health
Time Frame: 36 months
Self-rated health will be rated as: very good, good bad, very bad. The transition during monitoring to a less favorable modality than that announced at inclusion will be considered as a perceived deterioration in health
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Moustapha DRAME, PHD, Unversity hospital of Martinique

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2020

Primary Completion (Actual)

April 15, 2021

Study Completion (Actual)

April 13, 2023

Study Registration Dates

First Submitted

May 18, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 20_RIPH3-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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