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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03994562
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Information provided by (Responsible Party):

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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 ]

Information from the National Library of Medicine

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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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03994562

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Contact: Emmanuelle DURON, Md, PHd +33144596943
Contact: Isabelle d DUFOUR 0185781010

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Broca Hospital Recruiting
Paris, Ile De Frane, France, 75016
Contact: Djamila Krabchi, Ph       djamila/   
Paul Brousse Hospital Recruiting
Villejuif, Val De Marne, France, 94000
Contact: Emmanuelle Duron, Md, PHd    01 44 59 69 43   
Sponsors and Collaborators
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Principal Investigator: Emmanuelle Duron, Md, PHd APHP
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Responsible Party: Gérond'if Identifier: NCT03994562    
Other Study ID Numbers: 2018-A02925-50
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gérond'if:
Zarit scale
Additional relevant MeSH terms:
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Pathologic Processes