NCT05261061

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

February 28, 2022

Last Update Submit

June 29, 2022

Conditions

Keywords

COVID-191-year prognosisolder patients

Outcome Measures

Primary Outcomes (1)

  • One-year mortality

    1 year

Secondary Outcomes (4)

  • Activity of daily living (ADL) at 1 year

    1 year

  • SF-12 at one year

    1 year

  • Clinical Frailty Scale (CFS) at one year

    1 year

  • rehospitalization at one year

    1 year

Study Arms (2)

Old patients hospitalized in acute geriatric unit

Old patients hospitalized for other medical diagnosis in acute geriatric unit

Eligibility Criteria

Age75 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients hospitalized in acute geriatric unit for medical reason (COVID or other)

You may qualify if:

  • Age \>=75 years
  • Hospitalized for medical reason in acute geriatric unit
  • Alive at hospital discharge

You may not qualify if:

  • Patients hospitalized for surgical reason
  • Patients under legal protection
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de gériatrie, Hôpital Saint Antoine

Paris, 75012, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Hélène VALLET, MD, PhD

    AP-HP- Sorbonne université

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hélène VALLET, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 2, 2022

Study Start

July 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

June 30, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations