Clinical trial NCT03295110: Connected Solution of Assistance Dedicated to Caregivers and People With Alzheimer's Disease or Related Diseases
Official title: Lili Smart Study - Connected Solution of Assistance Dedicated to Caregivers and People With Alzheimer's Disease or Related Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer's disease and Related Disorders (ADRD)
natural caregiver
non-medical connected device
caregiver's burden
anxiety
costs
quality of life
depressive symptoms
independence
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Lili smart
First posted: 2017-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Caregiver's burden evolution
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Evolution of the caregiver's anxiety level
timeFrame: 3 months and 6 months after randomization
measure: Evolution of the caregiver's depressive symptomatology
timeFrame: 3 months and 6 months after randomization
measure: Evolution of the caregiver's quality of life
timeFrame: 3 months and 6 months after randomization
measure: Evolution of the patient's quality of life
timeFrame: 3 months and 6 months after randomization
measure: Evolution of the patient's independence
timeFrame: 3 months and 6 months after randomization
measure: Evolution of the caregiver's quality of life
timeFrame: 3 months and 6 months after randomization
measure: Evolution of the patient's quality of life
timeFrame: 3 months and 6 months after randomization
measure: Number of falls
timeFrame: 1 months, 3 months and 6 months after randomization
measure: Number of run aways
timeFrame: 1 months, 3 months and 6 months after randomization
measure: Number of drugs prescribed to the caregiver and the patient
timeFrame: at inclusion and at 6 months
measure: Indirect medical costs and direct non-medical costs
timeFrame: 6 months
measure: Evaluation of the caregiver's adherence to the Lili Smart solution
timeFrame: 7 months
measure: Evaluation of patient's adherence to the Lili Smart solution
timeFrame: 7 months
measure: Caregiver's burden evolution
timeFrame: 3 months after randomization
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Hopital des Charpennes
Study officials:
affiliation: Hospices Civils de Lyon
name: Pierre Krolak-Salmon, MD
role: PRINCIPAL_INVESTIGATOR
References: