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

NCT04414319 | Terminated

• 1 other identifier: 20_RIPH3-02
• Study Type: observational
• Target: 170
• Locations: 3 countries
• Sites: 5

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.

Conditions

SARS-CoV 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Hospital readmission

  1 month follow-up

• Nursing home admission

  36 months

• All-cause mortality

  Inclusion and 36 months

• change in self-rated health

  36 months

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patient under formal guardianship or trusteeship.

Sponsors & Collaborators

• University Hospital Center of Martinique: lead

Study Sites (5)

University hospital of Rennes

Rennes, 35000, France

Location

Va de Lys-Ramsay Gds group Clinic

Tourcoing, 59200, France

Location

Hopsital of Valenciennes

Valenciennes, 59300, France

Location

University hospital of Guadeloupe

Les Abymes, 97139, Guadeloupe

Location

University hospital of Martinique

Fort-de-France, 97261, Martinique

Location

Study Officials

• Moustapha DRAME, PHD

  Unversity hospital of Martinique

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 4, 2020
• Study Start: April 15, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 13, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1); GU (1); FR (3)