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

12 maart 2018 bijgewerkt door: Hospices Civils de Lyon

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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Verwacht)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Frankrijk
      • Villeurbanne, Frankrijk, 69100
        • Werving
        • Hopital des Charpennes
        • Contact:
          • Pierre Krolak Salmon, Pr

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Functionalities of the Lili Smart Solution activated
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.
Ander: 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.
Andere namen:
  • Non-medical connected device (Lili Smart solution) with active functionalities
Ander: Functionalities of the Lili Smart Solution non activated
Lili Smart watch worn by the participants and sensors placed at home with their functionalities inactivated. Absence of the web / mobile application.
Ander: 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.
Andere namen:
  • Non-medical connected device (Lili Smart solution) with inactive functionalities

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Caregiver's burden evolution
Tijdsspanne: 6 months after randomization
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Evolution of the caregiver's anxiety level
Tijdsspanne: 3 months and 6 months after randomization
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
Tijdsspanne: 3 months and 6 months after randomization
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
Tijdsspanne: 3 months and 6 months after randomization
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
Tijdsspanne: 3 months and 6 months after randomization
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
Tijdsspanne: 3 months and 6 months after randomization
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
Tijdsspanne: 3 months and 6 months after randomization
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
Tijdsspanne: 3 months and 6 months after randomization
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
Tijdsspanne: 1 months, 3 months and 6 months after randomization
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
Tijdsspanne: 1 months, 3 months and 6 months after randomization
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
Tijdsspanne: at inclusion and at 6 months
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
Tijdsspanne: 6 months
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
Tijdsspanne: 7 months
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
Tijdsspanne: 7 months
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
Tijdsspanne: 3 months after randomization
Natural caregiver's burden evolution after 3 months of follow-up. Assessement with the Zarit scale
3 months after randomization

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospices Civils de Lyon

Medewerkers

Lili smart

Onderzoekers

  • Hoofdonderzoeker: Pierre Krolak-Salmon, MD, Hospices Civils de Lyon

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

13 februari 2018

Primaire voltooiing (Verwacht)

1 september 2019

Studie voltooiing (Verwacht)

1 september 2019

Studieregistratiedata

Eerst ingediend

12 september 2017

Eerst ingediend dat voldeed aan de QC-criteria

26 september 2017

Eerst geplaatst (Werkelijk)

27 september 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 maart 2018

Laatste update ingediend die voldeed aan QC-criteria

12 maart 2018

Laatst geverifieerd

1 september 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 69HCL16_0706

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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