Prognosis of Geriatric Patients 1 Year After Hospitalizat... | NCT05261061

Studies
Prognosis of Geriatric Patients 1 Year After Hospitalization for COVID-19

NCT05261061

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Jun 30, 2022Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IDRCB 2021-A02684-37	Other Identifier	ANSM

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2022Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Feb 28, 2022

First Submission Date that Met QC Criteria

Feb 28, 2022

First Posted Date

Mar 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2022

Last Update Posted Date

Jun 30, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Old patients hospitalized in acute geriatric unit
Old patients hospitalized for other medical diagnosis in acute geriatric unit

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
One-year mortality		1 year

Secondary Outcomes

Measure	Description	Time Frame
Activity of daily living (ADL) at 1 year		1 year
SF-12 at one year	Quality of life	1 year
Clinical Frailty Scale (CFS) at one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hélène VALLET, MD, PhD	Contact	+33149282042		Helene.vallet@aphp.fr

Overall Officials

Name	Affiliation	Role
Hélène VALLET, MD, PhD	AP-HP- Sorbonne université	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de gériatrie, Hôpital Saint Antoine		Paris		75012	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

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Browse Branches

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