NCT05561101

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

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
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2024

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

September 27, 2022

Last Update Submit

February 28, 2023

Conditions

Keywords

Caregiver-patient dyedsEmergency Department

Outcome Measures

Primary Outcomes (1)

  • Measure of caregiver burden by the 7-item Zarit burden scale (Mini-zarit)

    1 month

Secondary Outcomes (8)

  • 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)

    At inclusion

  • Assessment of commorbidity risk according Charlson score

    At inclusion

  • +3 more secondary outcomes

Interventions

Assessment of caregiver burden after admision at Emergency Department of their elderly relative

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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.

You may not qualify if:

  • Hospitalized patient after emergency
  • Patient admitted to emergency for life-saving emergency
  • Patient living Nursing Home (EHPAD)
  • Language barrier
  • Absence of identified caregivers
  • Patients under guardianship
  • Oral opposition from the patient and caregiver to their data collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Department, Bichat Hospital

Paris, Île-de-France Region, 75018, France

RECRUITING

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • PATRY Claire, MD

    Extern Geriatric Mobile Team

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2022

First Posted

September 30, 2022

Study Start

September 20, 2022

Primary Completion

March 20, 2024

Study Completion

April 20, 2024

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations