NCT03295110

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

February 13, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

March 13, 2018

Status Verified

September 1, 2017

Enrollment Period

1.5 years

First QC Date

September 12, 2017

Last Update Submit

March 12, 2018

Conditions

Alzheimer Disease

Keywords

Alzheimer's disease and Related Disorders (ADRD)natural caregivernon-medical connected devicecaregiver's burdenanxietycostsquality of lifedepressive symptomsindependence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Evolution of the caregiver's anxiety level

    3 months and 6 months after randomization

  • Evolution of the caregiver's depressive symptomatology

    3 months and 6 months after randomization

  • Evolution of the caregiver's quality of life

    3 months and 6 months after randomization

  • Evolution of the patient's quality of life

    3 months and 6 months after randomization

  • Evolution of the patient's independence

    3 months and 6 months after randomization

  • +9 more secondary outcomes

Study Arms (2)

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.

Other: Functionalities of the Lili Smart Solution activated

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.

Other: Functionalities of the Lili Smart Solution non activated

Interventions

Functionalities of the Lili Smart Solution activatedOTHER

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.

Also known as: Non-medical connected device (Lili Smart solution) with active functionalities
Functionalities of the Lili Smart Solution activated
Functionalities of the Lili Smart Solution non activatedOTHER

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.

Also known as: Non-medical connected device (Lili Smart solution) with inactive functionalities
Functionalities of the Lili Smart Solution non activated

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • Known psychiatric disorders
  • Disabling motor and / or sensory impairment
  • Patient under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital des Charpennes

Villeurbanne, 69100, France

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Pierre Krolak-Salmon, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Viricel

CONTACT

4 72 43 25 01deborah.viricel@chu-lyon.fr

Romain Bachelet

CONTACT

4 72 43 22 25romain.bachelet@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 27, 2017

Study Start

February 13, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

March 13, 2018

Record last verified: 2017-09

Locations

FR(1)