依存している高齢者を自宅に留めておくための革新的なシステムに照らして、介護の影響を測定する (DIAPASON)
The purpose of this study is to compare life quality of patients taking care by DIAPASON 92 with patients or residents from control group EHPAD (retirement home)
調査の概要
詳細な説明
This study has two components: a quantitative component(for users and caregivers) and a qualitative component (for users, caregivers and professionals)
About population :
For quantitative component: the investigators have two arms:
- Diapason 92 arm: will be constitued by older patients with loss of autonomy, living at home and benefiting from Diapason 92 device
- Control arm: will be constituted by people residing at the EHPAD (retirement home)
For qualitative component: Study will cover 5 different populations since it concerns both:- - Diapason 92 professionals who work directly with users
- Daipason 92 Supervisory staff
- Diapason 92 professional partners, including referring physicians.
- The users
- Non-professional helpers of users
Conduct of study:
- About quantitative component:
After verification of eligibility criteria adapted to each centre and once the non-opposition has been collected and subjects have been included, the following data will be collected at M0, M3, M6 and M12:
- For patients : Start date of care by Diapason 92 or EHPAD, Quality of Life score, benefit evaluation, Socio-educational level, evaluation of disruptive behaviour disorders, economic indicators, somatic comorbidities, collection of psychiatric follow-up if available, independence, nutritional status, factors(s) that motivated care, cognitive assessment, balance assessment, depression screening, ergonomic assessment (only for Diapason 92
- Family caregiver: 3 measures will be collected: Measuring the burden by Zarit scale, self-assessment of his quality of life and psychological condition
- About quality component:
A socio-demographic heel will be collected for each participant interviewed who has given no objection to participating in the study. His agreement on the recording of his voice will also collected.
For all participants, following data will be collected: Age, sex, occupation, date and duration of the interview, relationship with the Diapason 92 user (for family caregivers) and the recovery of socio-demographic data of the case report form (for users)
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
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Île-de-France Region
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Paris、Île-de-France Region、フランス、75013
- Geriatric department , Broca 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
For quantitative component: we have two arms:
- Diapason 92 arm: will be constitued by older patients with loss of autonomy, living at home and benefiting from Diapason 92 device
- Control arm: will be constituted by people residing at the EHPAD (retirement home)
For qualitative component: Study will cover 5 different populations since it concerns both:
- Diapason 92 professionals who work directly with users
- Daipason 92 Supervisory staff
- Diapason 92 professional partners, including referring physicians.
- The users
- Non-professional helpers of users
説明
Patient/Resident Inclusion Criteria
- Age ≥ 60 years old.
- (Group iso-resources) GIR ≤ 4
- Beneficiary of treatment by Diapason 92 or resident at EHPAD Aulagnier for more than 6 months.
- Not exhibiting severe disruptive behaviour disorders (on NPI-ES all FXG 12 and resonance 4 scores).
- Affiliate or entitled to a sickness insurance scheme
- Patient or legal representative expressed no objection
Patient/Resident Exclusion Criteria:
- Age < 60 years old
- GIR ˃ 4
- Not affiliated or entitled to a sickness insurance scheme
- Patient or legal representative did not express no objection
Professionals and caregivers Inclusion Criteria:
- Exercise within Diapason 92 device or be identified as assisting a Diapason 92 user or be a professional partner of Diapason 92 device
- Have expressed no objection to participating in the study.
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:CASE_CONTROL
- 時間の展望:OTHER
コホートと介入
グループ/コホート |
|---|
|
DIAPASON 92 arm
Arm will be constitued by older patients with loss of autonomy, living at home benefiting from the device DIAPASON 92 (Innovative support system for elderly people in their homes) |
|
Control arm
Arm will be constituted by people residing at the EHPAD (retirement home) |
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assessment of life quality according Nottingham Health Profile (NHP) scale
時間枠:12 months
|
Difference in 12-month quality of life scores (Nottingham Health Profile) between the 2 groups (Diapason 92 and EHPAD). |
12 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Autonomy, gerontology Iso Resources Group (AGGIR) スケールによる高齢者の自律性の喪失レベルの評価
時間枠:12ヶ月
|
12ヶ月
|
|
Lawton Instrumental Activities of Daily Living (IADL) スケールによる機能状態の評価
時間枠:12ヶ月
|
12ヶ月
|
|
日常生活動作(ADL)スケールによる日常生活動作、セルフケア、自立の評価
時間枠:12ヶ月
|
12ヶ月
|
|
チャールソンスケールによる併存疾患の評価
時間枠:12ヶ月
|
12ヶ月
|
|
Mini-Mental State Examination (MMSE) スケールによる認知機能の評価
時間枠:12ヶ月
|
12ヶ月
|
|
(NPI-ES)スケールによる破壊的行動障害の評価
時間枠:12ヶ月
|
12ヶ月
|
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Geriatric Depression Scale(GDS)スケールによる老年性うつ病の評価
時間枠:12ヶ月
|
12ヶ月
|
|
身近な介護者の負担を測定する人気介護者自己申告測定負担(ZARIT)
時間枠:12ヶ月
|
12ヶ月
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Olivier Phd Hanon、Geriatric department, Broca hospital (Paris)
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
本研究に関する用語
その他の研究ID番号
- 2018-A03183-52
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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