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出境医 / 临床实验 / Determinants of Frailty Among of Informal Caregivers of Demented Patient (DELFAF)

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

Study Description
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.

Condition or disease
Fragility

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Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants of Frailty Among of Informal Caregivers of Demented Patient Evaluated in Day Care Hospital.
Actual Study Start Date : February 8, 2019
Estimated Primary Completion Date : August 7, 2020
Estimated Study Completion Date : August 7, 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. Measuring cognitive impairment according Mini-Mental State Examination (MMSE) scores [ Time Frame: Day 0 ]
  2. Screening for a nutritional disorder according Body Mass Index (BMI) score [ Time Frame: Day 0 ]
  3. Assessment of verbal episodic memory according Grober and Buschke's test [ Time Frame: Day 0 ]
  4. Screening of the undernutrition according mini nutritional assessment (MNA) [ Time Frame: Day 0 ]
  5. Assessment of anxiety according Goldberg scale [ Time Frame: Day 0 ]
  6. Assessment of humor in geriatrics according Geriatric Depression Scale (GDS) [ Time Frame: Day 0 ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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
Contacts and Locations

Contacts
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Contact: Emmanuelle DURON, Md, PHd +33144596943 emmanuelle.duron@aphp.fr
Contact: Isabelle d DUFOUR 0185781010 isabelle.dufour@gerondif.org

Locations
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France
Broca Hospital Recruiting
Paris, Ile De Frane, France, 75016
Contact: Djamila Krabchi, Ph       djamila/krabchi@aphp.fr   
Paul Brousse Hospital Recruiting
Villejuif, Val De Marne, France, 94000
Contact: Emmanuelle Duron, Md, PHd    01 44 59 69 43    emmanuelle.duron@aphp.fr   
Sponsors and Collaborators
Gérond'if
Investigators
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Principal Investigator: Emmanuelle Duron, Md, PHd APHP
Tracking Information
First Submitted Date January 22, 2019
First Posted Date June 21, 2019
Last Update Posted Date June 21, 2019
Actual Study Start Date February 8, 2019
Estimated Primary Completion Date August 7, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2019)
Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale [ Time Frame: Day 0 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 19, 2019)
  • Measuring cognitive impairment according Mini-Mental State Examination (MMSE) scores [ Time Frame: Day 0 ]
  • Screening for a nutritional disorder according Body Mass Index (BMI) score [ Time Frame: Day 0 ]
  • Assessment of verbal episodic memory according Grober and Buschke's test [ Time Frame: Day 0 ]
  • Screening of the undernutrition according mini nutritional assessment (MNA) [ Time Frame: Day 0 ]
  • Assessment of anxiety according Goldberg scale [ Time Frame: Day 0 ]
  • Assessment of humor in geriatrics according Geriatric Depression Scale (GDS) [ Time Frame: Day 0 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determinants of Frailty Among of Informal Caregivers of Demented Patient
Official Title Determinants of Frailty Among of Informal Caregivers of Demented Patient Evaluated in Day Care Hospital.
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Fragility
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 19, 2019)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 7, 2020
Estimated Primary Completion Date August 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03994562
Other Study ID Numbers 2018-A02925-50
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Gérond'if
Study Sponsor Gérond'if
Collaborators Not Provided
Investigators
Principal Investigator: Emmanuelle Duron, Md, PHd APHP
PRS Account Gérond'if
Verification Date June 2019