Connected Solution of Assistance Dedicated to Caregivers and People With Alzheimer's Disease or Related Diseases (Lili smart)
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.
研究概览
地位
条件
详细说明
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).
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Villeurbanne、法国、69100
- 招聘中
- Hopital des Charpennes
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接触：
- Pierre Krolak Salmon, Pr
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参与标准
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
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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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.
其他名称：
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其他：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.
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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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Caregiver's burden evolution
大体时间：6 months after randomization
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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
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6 months after randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evolution of the caregiver's anxiety level
大体时间：3 months and 6 months after randomization
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Evolution of the caregiver's anxiety level estimated with repeated measures with the Spielberger's State-Trait Anxiety Inventory (STAI Y-A / Y-B).
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3 months and 6 months after randomization
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Evolution of the caregiver's depressive symptomatology
大体时间：3 months and 6 months after randomization
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Evolution of the caregiver's depressive symptomatology estimated with repeated measures of the Beck Depression Inventory (BDI)
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3 months and 6 months after randomization
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Evolution of the caregiver's quality of life
大体时间：3 months and 6 months after randomization
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Evolution of the caregiver's quality of life estimated with repeated measures of the Quality of Life in Alzheilmer's Disease scale, caregiver version
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3 months and 6 months after randomization
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Evolution of the patient's quality of life
大体时间：3 months and 6 months after randomization
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Evolution of patient's quality of life estimated with repeated measures of the Quality of Life in Alzheilmer's Disease scale, patient version
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3 months and 6 months after randomization
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Evolution of the patient's independence
大体时间：3 months and 6 months after randomization
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Evolution of the patient's independence with repeated measures of the Instrumental Activities of Daily Life (IADL-E, 9 items).
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3 months and 6 months after randomization
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Evolution of the caregiver's quality of life
大体时间：3 months and 6 months after randomization
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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).
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3 months and 6 months after randomization
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Evolution of the patient's quality of life
大体时间：3 months and 6 months after randomization
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Evolution of patient's quality of life estimated with repeated measures of the Quality of Life with EQ-5D questionnaire (EuroQol Five Dimensions questionnaire).
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3 months and 6 months after randomization
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Number of falls
大体时间：1 months, 3 months and 6 months after randomization
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Number of times the patient has fallen after 1 month, 3 months and 6 months.
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1 months, 3 months and 6 months after randomization
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Number of run aways
大体时间：1 months, 3 months and 6 months after randomization
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Number of times the patient has ran away after 1 month, 3 months and 6 months.
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1 months, 3 months and 6 months after randomization
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Number of drugs prescribed to the caregiver and the patient
大体时间：at inclusion and at 6 months
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Evolution of the number of drugs prescribed to the caregiver and the patient at inclusion and after 6 months of follow-up.
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at inclusion and at 6 months
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Indirect medical costs and direct non-medical costs
大体时间：6 months
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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
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6 months
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Evaluation of the caregiver's adherence to the Lili Smart solution
大体时间：7 months
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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).
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7 months
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Evaluation of patient's adherence to the Lili Smart solution
大体时间：7 months
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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).
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7 months
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Caregiver's burden evolution
大体时间：3 months after randomization
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Natural caregiver's burden evolution after 3 months of follow-up.
Assessement with the Zarit scale
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3 months after randomization
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合作者和调查者
合作者
调查人员
- 首席研究员：Pierre Krolak-Salmon, MD、Hospices Civils de Lyon
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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