認知症患者の非公式介護者のフレイルの決定要因 (DELFAF)
デイケア病院で評価された認知症患者の非公式介護者のフレイルの決定要因。
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Ile de Frane
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Paris、Ile de Frane、フランス、75016
- Broca Hospital
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Val de Marne
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Villejuif、Val de Marne、フランス、94000
- Paul Brousse Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
caregivers of demented patients who are aware of the day care hospital and who want to be assesed
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:COHORT
- 時間の展望:PROSPECTIVE
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Zarit負担スケールによる介護者の感情的、身体的、経済的負担の評価
時間枠:0日目
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0日目
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Mini-Mental State Examination (MMSE) スコアによる認知障害の測定
時間枠:0日目
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0日目
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ボディマス指数(BMI)スコアによる栄養障害のスクリーニング
時間枠:0日目
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0日目
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Grober と Buschke のテストによる言語エピソード記憶の評価
時間枠:0日目
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0日目
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ミニ栄養評価(MNA)による低栄養のスクリーニング
時間枠:0日目
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0日目
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ゴールドバーグ尺度による不安の評価
時間枠:0日目
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0日目
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Geriatric Depression Scale(GDS)による老年医学におけるユーモアの評価
時間枠:0日目
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0日目
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Emmanuelle Duron, Md, PHd、APHP
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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