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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05261061
Other study ID # APHP211505
Secondary ID IDRCB 2021-A0268
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2022
Est. completion date December 2022

Study information

Verified date June 2022
Source Assistance Publique - Hôpitaux de Paris
Contact Hélène VALLET, MD, PhD
Phone +33149282042
Email Helene.vallet@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Old patients hospitalized in Acute Geriatric Units are characterize by advanced age, frailty, high number of comorbidities, cognitive impairment and loss of functional autonomy. Although, intra-hospital mortality in geriatric population (out of COVID) is low (6%) the long-term prognosis is often worse (30 to 60% of loss of autonomy and 30% of one-year mortality among hospital survivors). For geriatric patients with COVID19, intra-hospital mortality is higher than in younger Covid patients (1), but also higher than in geriatric patients outside the Covid context (30 vs 6% (2, 3)). Our hypothesis is that geriatric patients surviving hospitalization for COVID-19 have a worse vital and functional prognosis at 12 months than geriatric patients surviving hospitalization for another medical reason.


Description:

Old patients hospitalized in Acute Geriatric Units are characterize by advanced age (average 85 years), frailty, high number of comorbidities, cognitive impairment and loss of functional autonomy.These particular state leads to multiple decompensations and the reason for initial hospitalization is often only the "tip of the iceberg". Although, intra-hospital mortality in geriatric population (out of COVID) is low (6%) the long-term prognosis is often worse (30 to 60% of loss of autonomy and 30% of one-year mortality among hospital survivors). For geriatric patients with COVID19, intra-hospital mortality is higher than in younger Covid patients (1), but also higher than in geriatric patients outside the Covid context (30 vs 6% (2, 3)). This excess mortality is all the more surprising as these patients seem to have fewer comorbidities than those usually hospitalized in acute geriatric units. Our hypothesis is that geriatric patients surviving hospitalization for COVID-19 have a worse vital and functional prognosis at 12 months than geriatric patients surviving hospitalization for another medical reason.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - Age >=75 years - Hospitalized for medical reason in acute geriatric unit - Alive at hospital discharge Exclusion Criteria: - Patients hospitalized for surgical reason - Patients under legal protection - Patient refusal

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Service de gériatrie, Hôpital Saint Antoine Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary One-year mortality 1 year
Secondary Activity of daily living (ADL) at 1 year 1 year
Secondary SF-12 at one year Quality of life 1 year
Secondary Clinical Frailty Scale (CFS) at one year 1 year
Secondary rehospitalization at one year 1 year
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