- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03994562
치매환자의 비공식 간병인의 노쇠 결정요인 (DELFAF)
주간보호병원에서 평가한 치매환자 간병인의 노쇠 결정요인.
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ile de Frane
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Paris, Ile de Frane, 프랑스, 75016
- Broca Hospital
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Val de Marne
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Villejuif, Val de Marne, 프랑스, 94000
- Paul Brousse Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
caregivers of demented patients who are aware of the day care hospital and who want to be assesed
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Zarit 부담 척도에 따른 간병인의 정서적, 신체적, 재정적 부담 평가
기간: 0일
|
0일
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
MMSE(Mini-Mental State Examination) 점수에 따른 인지 장애 측정
기간: 0일
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0일
|
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체질량지수(BMI) 점수에 따른 영양장애 선별
기간: 0일
|
0일
|
|
Grober와 Buschke의 테스트에 따른 언어 삽화 기억의 평가
기간: 0일
|
0일
|
|
미니영양평가(MNA)에 따른 영양결핍 선별
기간: 0일
|
0일
|
|
Goldberg 척도에 따른 불안 평가
기간: 0일
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0일
|
|
GDS(Geriatric Depression Scale)에 따른 노인의 유머 평가
기간: 0일
|
0일
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Emmanuelle Duron, Md, PHd, APHP
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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