Clinical trial NCT04414319: Severe Acute Respiratory Syndrome-Coronavirus-2 and Loss of Autonomy in the Elderly
Official title: Impact of SARS-CoV-2 Infection in a Population Aged 70 Years or Older on Loss of Autonomy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: SARS-CoV 2
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 170
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Loss of autonomy
timeFrame: 36 months
Secondary outcomes:
measure: Hospital readmission
timeFrame: 1 month follow-up
measure: Nursing home admission
timeFrame: 36 months
measure: All-cause mortality
timeFrame: Inclusion and 36 months
measure: change in self-rated health
timeFrame: 36 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: University hospital of Rennes
city: Tourcoing
country: France
facility: Va de Lys-Ramsay Gds group Clinic
city: Valenciennes
country: France
facility: Hopsital of Valenciennes
city: Les Abymes
country: Guadeloupe
facility: University hospital of Guadeloupe
city: Fort-de-France
country: Martinique
facility: University hospital of Martinique
Study officials:
affiliation: Unversity hospital of Martinique
name: Moustapha DRAME, PHD
role: STUDY_DIRECTOR
References: