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| Name | Class |
|---|---|
| Lili smart | UNKNOWN |
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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.
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:
In addition to the social impact measurement, the study aims to demonstrate the medico-economic impact of Lili smart solution as follow:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functionalities of the Lili Smart Solution activated | Experimental | 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. |
|
| Functionalities of the Lili Smart Solution non activated | Other | Lili Smart watch worn by the participants and sensors placed at home with their functionalities inactivated. Absence of the web / mobile application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functionalities of the Lili Smart Solution activated | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver's burden evolution | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the caregiver's anxiety level | 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 |
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Inclusion Criteria:
Caregiver inclusion's criteria :
Patient Inclusion Criteria:
Exclusion Criteria:
Patients exclusion's criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah Viricel | Contact | 4 72 43 25 01 | +33 | deborah.viricel@chu-lyon.fr |
| Romain Bachelet | Contact | 4 72 43 22 25 | +33 | romain.bachelet@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre Krolak-Salmon, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital des Charpennes | Recruiting | Villeurbanne | 69100 | France |
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| Functionalities of the Lili Smart Solution non activated | Other | 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. |
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Natural caregiver's burden evolution after 3 months of follow-up. Assessement with the Zarit scale | 3 months after randomization |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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