痴呆症患者非正式照顾者虚弱的决定因素 (DELFAF)
在日间护理医院评估的痴呆症患者非正式护理人员中虚弱的决定因素。
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.
研究概览
地位
地位
详细说明
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.
研究类型
研究类型
注册 (实际的)
注册
联系人和位置
学习地点
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Ile de Frane
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Paris、Ile de Frane、法国、75016
- Broca Hospital
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Val de Marne
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Villejuif、Val de Marne、法国、94000
- Paul Brousse Hospital
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参与标准
资格标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
caregivers of demented patients who are aware of the day care hospital and who want to be assesed
描述
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
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
研究衡量的是什么?
主要结果指标
主要结果指标
结果测量 |
大体时间 |
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根据 Zarit 负担量表评估照顾者的情感、身体和经济负担
大体时间:第 0 天
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第 0 天
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次要结果测量
次要结果测量
结果测量 |
大体时间 |
|---|---|
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根据简易精神状态检查 (MMSE) 分数测量认知障碍
大体时间:第 0 天
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第 0 天
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根据体重指数 (BMI) 评分筛查营养障碍
大体时间:第 0 天
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第 0 天
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根据 Grober 和 Buschke 的测试评估言语情景记忆
大体时间:第 0 天
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第 0 天
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根据微型营养评估(MNA)筛查营养不良
大体时间:第 0 天
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第 0 天
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根据戈德堡量表评估焦虑
大体时间:第 0 天
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第 0 天
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根据老年抑郁量表 (GDS) 评估老年病学中的幽默感
大体时间:第 0 天
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第 0 天
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合作者和调查者
调查人员
调查人员
- 首席研究员:Emmanuelle Duron, Md, PHd、APHP
研究记录日期
研究主要日期
学习开始 (实际的)
学习开始
初级完成 (实际的)
初级完成
研究完成 (实际的)
研究完成
研究注册日期
首次提交
首次提交
首先提交符合 QC 标准的
首先提交符合 QC 标准的
首次发布 (实际的)
首次发布
研究记录更新
最后更新发布 (实际的)
最后更新发布
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
最后验证
最后验证
更多信息
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