NCT03994562

Brief Summary

Frailty, a transitional state between successful and pathological aging, may be benefit from early multi-interventional intervention. Fried's criteria are the more commonly used criteria to diagnose frailty. The caregivers' burden increases caregivers' morbidity .The main objective of the study was to assess the relationship between frailty among informal caregivers of demented patients and the caregiver's burden (Zarit scale). The Secondary objective was to assess determinants of frailty among caregivers.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

January 22, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

February 8, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

5.5 years

First QC Date

January 22, 2019

Last Update Submit

January 11, 2023

Conditions

Keywords

FrailtyCaregiversZarit scale

Outcome Measures

Primary Outcomes (1)

  • Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale

    Day 0

Secondary Outcomes (6)

  • Measuring cognitive impairment according Mini-Mental State Examination (MMSE) scores

    Day 0

  • Screening for a nutritional disorder according Body Mass Index (BMI) score

    Day 0

  • Assessment of verbal episodic memory according Grober and Buschke's test

    Day 0

  • Screening of the undernutrition according mini nutritional assessment (MNA)

    Day 0

  • Assessment of anxiety according Goldberg scale

    Day 0

  • +1 more secondary outcomes

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

caregivers of demented patients who are aware of the day care hospital and who want to be assesed

You may qualify if:

  • caregivers of demented patients ,
  • over \> 65 years old,
  • who accept exhaustive evalutaion in day care hospital, who agree for ther data to be recorded (anonymously) for an observational study

You may not qualify if:

  • No affliation to French social insurance system
  • People under tutorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Broca Hospital

Paris, Ile de Frane, 75016, France

RECRUITING

Paul Brousse Hospital

Villejuif, Val De Marne, 94000, France

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Emmanuelle Duron, Md, PHd

    APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuelle DURON, Md, PHd

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 22, 2019

First Posted

June 21, 2019

Study Start

February 8, 2019

Primary Completion

August 8, 2024

Study Completion

February 1, 2025

Last Updated

January 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations