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

SARS-CoV 2 Clinical Trial

— CovAged  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04414319
• Other study ID #: 20_RIPH3-02
• Status: Terminated
• Start date: April 15, 2020
• Est. completion date: April 13, 2023

Study information

• Verified date: July 2023
• Source: University Hospital Center of Martinique
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 170
• Est. completion date: April 13, 2023
• Est. primary completion date: April 15, 2021
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• SARS-CoV 2

Locations

Country	Name	City	State
France	University hospital of Rennes	Rennes
France	Va de Lys-Ramsay Gds group Clinic	Tourcoing
France	Hopsital of Valenciennes	Valenciennes
Guadeloupe	University hospital of Guadeloupe	Les Abymes
Martinique	University hospital of Martinique	Fort-de-France

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Center of Martinique

Countries where clinical trial is conducted

France,  Guadeloupe,  Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loss of autonomy	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	Hospital readmission	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
Secondary	Nursing home admission	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
Secondary	All-cause mortality	Death considered will be those occurring between inclusion and the end of follow-up	Inclusion and 36 months
Secondary	change in self-rated health	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