Evolution of the Health Status of Caregivers After the Admission of Their Elderly Relative to the Emergency Department (ETAP-U)

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

Study Overview

• Status: Recruiting
• Conditions: Caregiver-patient Dyeds; Patient Without Cognitive Disorders
• Intervention / Treatment: Other: Caregivers burden

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

• Study Type: Observational
• Enrollment (Anticipated): 125

Contacts and Locations

• Study Contact: Name: DUFOUR Isabelle; Phone Number: +33 (0) 185781010; Email: isabelle.dufour@gerondif.org
• Study Contact Backup: Name: LUCAS Prisca, PhD; Phone Number: +33 (0) 185781010; Email: prisca.lucas@gerondif.org

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75018
      • Recruiting
      • Emergency Department, Bichat Hospital
      • Contact: PATRY Claire, MD; Phone Number: +33(0)153111818; Email: claire.patry@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Family-Based
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of commorbidity risk according Charlson score		At inclusion
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		At inclusion
Assessment of complications risks according Triage Risk Screening Tool score (TRST)		At inclusion
Assessment of cognitive state of elderly patients according Abbreviated Mental Test 4 score (AMT-4)	If score < 4 must search for neurocognitive disorders	At inclusion
Assessment of quality of life of cargivers according SF-12 score		1 month
Measure of caregiver satisfaction according Likert scale		1 month
Measure of resilience capacities acoording Brief Resilience Scale (BRS)		At inclusion

Collaborators and Investigators

• Sponsor: Gérond'if
• Investigators: Study Chair: PATRY Claire, MD, Extern Geriatric Mobile Team

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Anticipated): March 20, 2024
• Study Completion (Anticipated): April 20, 2024

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Emergency Department; Caregiver-patient dyeds
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurocognitive Disorders; Disease Attributes; Emergencies; Cognition Disorders
• Other Study ID Numbers: 2022-A01294-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No