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

12 de março de 2018 atualizado por: 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.

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Descrição detalhada

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).

Tipo de estudo

Intervencional

Inscrição (Antecipado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • França
      • Villeurbanne, França, 69100
        • Recrutamento
        • Hopital des Charpennes
        • Contato:
          • Pierre Krolak Salmon, Pr

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

50 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Outro: 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.
Outros nomes:
  • Non-medical connected device (Lili Smart solution) with active functionalities
Outro: 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.
Outro: 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.
Outros nomes:
  • Non-medical connected device (Lili Smart solution) with inactive functionalities

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Caregiver's burden evolution
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Evolution of the caregiver's anxiety level
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 3 months after randomization
Natural caregiver's burden evolution after 3 months of follow-up. Assessement with the Zarit scale
3 months after randomization

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hospices Civils de Lyon

Colaboradores

Lili smart

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

13 de fevereiro de 2018

Conclusão Primária (Antecipado)

1 de setembro de 2019

Conclusão do estudo (Antecipado)

1 de setembro de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

12 de setembro de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de setembro de 2017

Primeira postagem (Real)

27 de setembro de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de março de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de março de 2018

Última verificação

1 de setembro de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 69HCL16_0706

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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