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PROVID-Ger: Prognosis of Geriatric Patients 1 Year After Hospitalization for COVID-19

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05261061
Collaborator
(none)
1,000
Enrollment
1
Location
5
Anticipated Duration (Months)
198.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Prognosis of Geriatric Patients 1 Year After Hospitalization for COVID-19
    Anticipated Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Old patients hospitalized in acute geriatric unit
    Old patients hospitalized for other medical diagnosis in acute geriatric unit

    Outcome Measures

    Primary Outcome Measures

    1. One-year mortality [1 year]

    Secondary Outcome Measures

    1. Activity of daily living (ADL) at 1 year [1 year]

    2. SF-12 at one year [1 year]

      Quality of life

    3. Clinical Frailty Scale (CFS) at one year [1 year]

    4. rehospitalization at one year [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de gériatrie, Hôpital Saint Antoine Paris France 75012

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Hélène VALLET, MD, PhD, AP-HP- Sorbonne université

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT05261061
    Other Study ID Numbers:
    • APHP211505
    • IDRCB 2021-A02684-37
    First Posted:
    Mar 2, 2022
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    COVID-19
    1-year prognosis
    older patients
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jun 30, 2022