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Connected Solution of Assistance Dedicated to Caregivers and People With Alzheimer's Disease or Related Diseases (Lili smart)

2018年3月12日 更新者：Hospices Civils de Lyon

Lili Smart Study - Connected Solution of Assistance Dedicated to Caregivers and People With Alzheimer's Disease or Related Diseases

Alzheimer's disease and related diseases (ADRD) are a major public health issue. In France, nearly 900,000 people have ADRD, which represents about 70% of dementia cases, and the expected prevalence for 2020 is 1.2 million.

Patients with ADRD have cognitive, behavioral and functional impairments that lead to progressive impairment of quality of life and autonomy. Maintaining them at home depends predominantly on their caregivers, mainly family, spouse or child. By definition, the caregiver is "the person who provides partial or total support to an elderly dependent person or a person with a disability in the vicinity of the victim for the activities of daily life".

The investment of caregivers is therefore both human and financial, representing a greater or lesser burden. This burden can significantly affect their quality of life. Indeed, studies have shown that caregivers suffer from depletion, anxiety, depression and sleep disorders resulting in a deterioration of their health, leading them to greater care consumption. They would be more prone to cardiovascular diseases and cancer.

A review of the literature from 2009 examined 66 studies evaluating the contribution of various technologies targeting demented patients and their caregivers. Of these, only 10 dealt with independence at home and the well-being of the patient and his / her caregiver. The main limitations of these studies are the small samples (ranging from 1 to 6 patients), the degree of cognitive degradation (mainly moderately severe) and the lack of standardized assessment.

Although new technologies promise powerful home-based solutions, studies evaluating their efficacy for patients with ADRD and their caregivers remain scarce and fragile at the level of evidence due to methodological biases.

調査の概要

状態

わからない

条件

介入・治療

詳細な説明

Description of the intervention: Lili Smart solution consists of an application for caregivers (web / mobile), a GSM watch worn by the patient, smart sensors placed at different locations of the patient's home and a support service 24 / 24 and 7/7.

Objectives: The main objective is to evaluate the impact of the Lili Smart solution on the burden felt by caregivers of patients with ADRD at 3 months and at 6 months of follow-up.

The secondary objectives are to evaluate the impact of the Lili Smart solution at 3 months and 6 months of follow-up on:

  • The anxiety of the caregiver of the patient with ADRD;
  • Depression of the caregiver of the patient with ADRD;
  • The quality of life of the caregiver of the patient with ADRD;
  • The quality of life of the patient with ADRD,
  • The level of functional autonomy of the patient with ADRD.
  • The risks associated with the functional decline (falls, run aways) of the patient with ADRD.

In addition to the social impact measurement, the study aims to demonstrate the medico-economic impact of Lili smart solution as follow:

  • The direct and indirect medical costs of the patient and the caregiver.

Patient and caregiver adherence to the Lili Smart solution will also be assessed as a secondary objective.

Methodology : This study is an interventional research on the human person meeting the definition 1 ° of article L1121-1 of the CSP and not relating to the products mentioned in article L. 5311-1 It is a randomized, controlled, single-blind, parallel-group, interventional, randomized, controlled trial in N = 60 patients and their primary caregiver with an observational phase (inactive device), and one interventional phase (activated device).

研究の種類

介入

入学 (予想される)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • フランス
      • Villeurbanne、フランス、69100
        • 募集
        • Hopital des Charpennes
        • コンタクト：
          • Pierre Krolak Salmon, Pr

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

50年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

Caregiver inclusion's criteria :

  • Natural caregiver helping the patient at least 6h / week for activities of daily living (if more than one caregiver, only one "referent" caregiver will be involved);
  • Can be the caregiver of only one patient of the study.
  • Having the ability to follow the study at the discretion of the investigator;
  • Having agreed to participate in the study;
  • Affiliated to a social security scheme;

Patient Inclusion Criteria:

  • Diagnosis of Alzheimer's disease or related disease;
  • Living at home
  • Age ≥ 50 years
  • Mini Mental State Examination (MMSE): 16-24 (included) (light to moderate);
  • Affiliated to a social security scheme;
  • Having agreed to participate in the study;
  • Having the physical and psychic abilities to follow the study according to the appreciation of the investigator.

Exclusion Criteria:

Patients exclusion's criteria:

  • Known psychiatric disorders
  • Disabling motor and / or sensory impairment
  • Patient under guardianship

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：Functionalities of the Lili Smart Solution activated
Lili Smart solution consists of an application for caregivers (web / mobile), a GSM watch worn by the patient, smart sensors placed at different locations of the patient's home and a support service 24 / 24 and 7/7.
他の：Functionalities of the Lili Smart Solution activated
Non-medical connected device (Lili Smart solution) activated : application for caregivers (web / mobile), GSM watch worn by the patient, smart sensors placed at different locations of the patient's home and a support service 24 /24 and 7/7.
他の名前：
  • Non-medical connected device (Lili Smart solution) with active functionalities
他の：Functionalities of the Lili Smart Solution non activated
Lili Smart watch worn by the participants and sensors placed at home with their functionalities inactivated. Absence of the web / mobile application.
他の：Functionalities of the Lili Smart Solution non activated
Non-medical connected device (Lili Smart solution) with inactive functionalities : watch worn by the participants and sensors placed at home with their functionalities inactivated. Absence of the web / mobile application.
他の名前：
  • Non-medical connected device (Lili Smart solution) with inactive functionalities

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
Caregiver's burden evolution
時間枠：6 months after randomization
Natural caregiver's burden evolution after 6 months of follow-up. Natural caregiver's burden evolution after 6 months of follow-up. Assessement with the Zarit scale
6 months after randomization

二次結果の測定

結果測定
メジャーの説明
時間枠
Evolution of the caregiver's anxiety level
時間枠：3 months and 6 months after randomization
Evolution of the caregiver's anxiety level estimated with repeated measures with the Spielberger's State-Trait Anxiety Inventory (STAI Y-A / Y-B).
3 months and 6 months after randomization
Evolution of the caregiver's depressive symptomatology
時間枠：3 months and 6 months after randomization
Evolution of the caregiver's depressive symptomatology estimated with repeated measures of the Beck Depression Inventory (BDI)
3 months and 6 months after randomization
Evolution of the caregiver's quality of life
時間枠：3 months and 6 months after randomization
Evolution of the caregiver's quality of life estimated with repeated measures of the Quality of Life in Alzheilmer's Disease scale, caregiver version
3 months and 6 months after randomization
Evolution of the patient's quality of life
時間枠：3 months and 6 months after randomization
Evolution of patient's quality of life estimated with repeated measures of the Quality of Life in Alzheilmer's Disease scale, patient version
3 months and 6 months after randomization
Evolution of the patient's independence
時間枠：3 months and 6 months after randomization
Evolution of the patient's independence with repeated measures of the Instrumental Activities of Daily Life (IADL-E, 9 items).
3 months and 6 months after randomization
Evolution of the caregiver's quality of life
時間枠：3 months and 6 months after randomization
Evolution of the caregiver's quality of life estimated with repeated measures of the Quality of Life with EQ-5D questionnaire (EuroQol Five Dimensions questionnaire).
3 months and 6 months after randomization
Evolution of the patient's quality of life
時間枠：3 months and 6 months after randomization
Evolution of patient's quality of life estimated with repeated measures of the Quality of Life with EQ-5D questionnaire (EuroQol Five Dimensions questionnaire).
3 months and 6 months after randomization
Number of falls
時間枠：1 months, 3 months and 6 months after randomization
Number of times the patient has fallen after 1 month, 3 months and 6 months.
1 months, 3 months and 6 months after randomization
Number of run aways
時間枠：1 months, 3 months and 6 months after randomization
Number of times the patient has ran away after 1 month, 3 months and 6 months.
1 months, 3 months and 6 months after randomization
Number of drugs prescribed to the caregiver and the patient
時間枠：at inclusion and at 6 months
Evolution of the number of drugs prescribed to the caregiver and the patient at inclusion and after 6 months of follow-up.
at inclusion and at 6 months
Indirect medical costs and direct non-medical costs
時間枠：6 months
Data for indirect medical costs and direct non-medical costs will be collected with the RUD LITE questionnaire and the Lyon CMRR's MEMORA database
6 months
Evaluation of the caregiver's adherence to the Lili Smart solution
時間枠：7 months
Evaluation of the caregiver's adherence to the Lili Smart solution after 7 months of follow-up (1 month of observation phase then 6 months of intervention) estimated through data collected in Lili Smart databases (number of connections to the application).
7 months
Evaluation of patient's adherence to the Lili Smart solution
時間枠：7 months
Evaluation of the patient's adherence to the Lili Smart solution after 7 months of follow-up (1 month of observation phase then 6 months of intervention) estimated through data collected in Lili Smart databases (number of hours when the watch is worn).
7 months
Caregiver's burden evolution
時間枠：3 months after randomization
Natural caregiver's burden evolution after 3 months of follow-up. Assessement with the Zarit scale
3 months after randomization

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Hospices Civils de Lyon

協力者

Lili smart

捜査官

  • 主任研究者：Pierre Krolak-Salmon, MD、Hospices Civils de Lyon

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年2月13日

一次修了 (予想される)

2019年9月1日

研究の完了 (予想される)

2019年9月1日

試験登録日

最初に提出

2017年9月12日

QC基準を満たした最初の提出物

2017年9月26日

最初の投稿 (実際)

2017年9月27日

学習記録の更新

投稿された最後の更新 (実際)

2018年3月13日

QC基準を満たした最後の更新が送信されました

2018年3月12日

最終確認日

2017年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 69HCL16_0706

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

いいえ

米国FDA規制機器製品の研究

いいえ

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