Determinants of Frailty Among of Informal Caregivers of Demented Patient (DELFAF)

Determinants of Frailty Among of Informal Caregivers of Demented Patient Evaluated in Day Care Hospital.

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.

Study Overview

• Status: Recruiting
• Conditions: Fragility

Detailed Description

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 :

• Loss of weight > 4.5 kg over one year,
• Self-reported exhaustion,
• Low muscle strength (handgrip <20% norm for age and sex),
• Low physical activity
• Low gait speed (<0.8m/s). According to the number of Fried's criteria, subjects are considered frail (≥ 3 Fried's criteria), pre-frail (1-2 Fried's criteria) or robust (0 Fried's criterion).

A large proportion of care is believed to be delivered by informal caregivers (e.g., spouses, next of kin). The caregivers' burden experienced as "enduring stress and frustration" due to caregiving, affects caregivers' mental health with depression, anxiety and sleep disorders, increases caregivers' morbidity and mortality. Multi-interventional studies (including physical and psychological wellbeing) have proven their accuracy to improve quality of life of caregivers.

In France, caregivers (>60 years) of demented people number have been estimate to 3.3 million (DREES).

For more than one year, in the Broca memory center (3000 patients/ years), caregivers can benefit from a comprehensive medico-psychosocial assessment during a day care hospital. Frailty is assessed in usual care. Two caregivers a week benefit from this assessment. The same day care hospital has been implemented in the "Paul Brousse" hospital (100 patients/year) : One caregiver a week benefit from this assessment.

Main objective:

To assess the relationship between frailty among informal caregivers of demented patients and the caregiver's burden (Zarit scale).

Secondary objective:

To assess determinants of frailty among caregivers.

Main outcome :

Caregiver burden will be determined according to the Zarit scale. The Zarit scale is an auto-questionnaire which includes 22 questions (rated from 0 to 4 points) and scores out of 88. A higher score reflects a higher caregiver burden.

Frailty will be defined by Fried criteria. Subjects will be considered as frail (≥ 3 Fried's criteria), pre-frail (1-2 Fried's criteria) or robust (0 Fried's criteria).

Secondary outcomes

• Age, sex, educational level
• Treatments et polypharmacy (≥ 4 treatments)
• Neuropsychological test if cognitive complaint : caregivers will be categorized as cognitively normal, mild cognitive impairment or dementia.
• Depression according to the Pichot scale and the Geriatric Depression Scale.
• Anxiety according to the Goldberg scale
• Nutritional Assessment: mini nutritional assessment and body mass index.

Feasibility :

Eighty caregivers will be included in the Broca hospital and 40 in the Paul Brousse hospital. To reach the calculated number of subjects to include (n=120), inclusions will take place during 1 year and a half.

Statistical analysis

Main objective :

To disclose a difference in the Zarit score of 11 points (retrospective analysis of collected data) with 80% power and α 5% risk, 120 subjects have to be included. The population will be described and factors associated with the Zarit scale in uni-variate analysis will be studied in a multiple linear regression model.

Analysis will be also performed according to 3 groups: frail, pre-frail and robust.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Emmanuelle DURON, Md, PHd; Phone Number: +33144596943; Email: emmanuelle.duron@aphp.fr
• Study Contact Backup: Name: Isabelle d DUFOUR; Phone Number: 0185781010; Email: isabelle.dufour@gerondif.org

Study Locations

• France
  • Ile De Frane
    • Paris, Ile De Frane, France, 75016
      • Recruiting
      • Broca Hospital
      • Contact: Djamila Krabchi, Ph; Email: djamila/krabchi@aphp.fr
  • Val De Marne
    • Villejuif, Val De Marne, France, 94000
      • Recruiting
      • Paul Brousse Hospital
      • Contact: Emmanuelle Duron, Md, PHd; Phone Number: 01 44 59 69 43; Email: emmanuelle.duron@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale	Day 0

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Assessment of humor in geriatrics according Geriatric Depression Scale (GDS)	Day 0

Collaborators and Investigators

• Sponsor: Gérond'if
• Investigators: Principal Investigator: Emmanuelle Duron, Md, PHd, APHP

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2019
• Primary Completion (Anticipated): August 8, 2024
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Caregivers; Frailty; Zarit scale
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 2018-A02925-50

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