Evolution of the Health Status of Caregivers After the Ad... | NCT05561101

Studies
Evolution of the Health Status of Caregivers After the Admission of Their Elderly Relative to the Emergency Department

NCT05561101

Sponsor

Gérond'if

Status

Unknown status

Last Update Posted

Mar 1, 2023Actual

Enrollment

125Estimated

Phase

Not provided

Conditions

Caregiver-patient Dyeds
Patient Without Cognitive Disorders

Interventions

Caregivers burden

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

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2022Actual

Primary Completion Date

Mar 20, 2024Estimated

Completion Date

Apr 20, 2024Estimated

First Submitted Date

Sep 27, 2022

First Submission Date that Met QC Criteria

Sep 27, 2022

First Posted Date

Sep 30, 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

Feb 28, 2023

Last Update Posted Date

Mar 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The main objective of this non-interventional, propective and multipercentric study is to Assess the evolution of caregiver burden 1 month after their elderly relative's Emergency Department (ED) admission

Detailed Description

The aim purpose of this non-interventional, prospertive study is to compare the evolution of caregiver burden between inclusion and 1month after their elderly relative's ED admission.

Inclusion of caregivers - patients dyads, meeting inclusion criteria and agreeing to participate, is carried out by geriatric mobile teams (EMG) working within Emergengy Department.

At inclusion the following data will be collected:

For the patient :

Presence of neurocognitive disorders
Sociodemographic data (age, gender, lifestyle)
Patient comorbidities
Autonomy and independence
Risk of early readmission and loss of autonomy

For the caregiver:

Socio-demographic data
The caregiver's burden
Quality of life
Resilience capacity will be measured

The follow-up of the caregiver is carried out 1 month after the passage of his elderly relative to Emergency Department (at inclusion). The levels of burden and quality of life as well as the aids set up at home will be collected

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

125Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Caregivers burden	Other	Assessment of caregiver burden after admision at Emergency Department of their elderly relative

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure of caregiver burden by the 7-item Zarit burden scale (Mini-zarit)		1 month

Secondary Outcomes

Measure	Description	Time Frame
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale		At inclusion
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult caregivers - patients aged 75 and over dyads consulting in Emergency Department and living at home
Patients admitted to the emergency department for less than 48 hours for which a return home is decided
Non-verbal opposition of the patient and caregiver to the collection of their data.

Exclusion Criteria:

Hospitalized patient after emergency
Patient admitted to emergency for life-saving emergency
Patient living Nursing Home (EHPAD)
Language barrier
Absence of identified caregivers
Severe cognitive impairment as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and absence relative at time of inclusion
Patients under guardianship
Oral opposition from the patient and caregiver to their data collection.

Accepts Healthy Volunteers

Yes

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

Patients - caregivers dyads aged 75 years and over, after admission to the elderly Emergency Department, without indication for hospitalization and living at home outside Nursing Home (EHPAD)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
DUFOUR Isabelle	Contact	+33 (0) 185781010		isabelle.dufour@gerondif.org
LUCAS Prisca, PhD	Contact	+33 (0) 185781010		prisca.lucas@gerondif.org

Overall Officials

Name	Affiliation	Role
PATRY Claire, MD	Extern Geriatric Mobile Team	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emergency Department, Bichat Hospital	Recruiting	Paris	Île-de-France Region	75018	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
D004630	Emergencies

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided