Alzheimer Disease Clinical Trial
Official title:
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.
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).
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