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

Alzheimer Disease Clinical Trial

— Lili smart  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03295110
• Other study ID #: 69HCL16_0706
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2017
• Last updated: March 12, 2018
• Start date: February 13, 2018
• Est. completion date: September 2019

Study information

• Verified date: September 2017
• Source: Hospices Civils de Lyon
• Contact: Deborah Viricel
• Phone: 4 72 43 25 01
• Email: deborah.viricel[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
France	Hopital des Charpennes	Villeurbanne

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	Lili smart

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Evolution of the caregiver's depressive symptomatology	Evolution of the caregiver's depressive symptomatology estimated with repeated measures of the Beck Depression Inventory (BDI)	3 months and 6 months after randomization
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Caregiver's burden evolution	Natural caregiver's burden evolution after 3 months of follow-up. Assessement with the Zarit scale	3 months after randomization