Connected Solution of Assistance Dedicated to Caregivers and People With Alzheimer's Disease or Related Diseases (Lili smart)
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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).
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Villeurbanne, France, 69100
- Recrutement
- Hopital des Charpennes
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Contact:
- Pierre Krolak Salmon, Pr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
Autres noms:
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Autre: 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.
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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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Caregiver's burden evolution
Délai: 6 months after randomization
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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
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6 months after randomization
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Evolution of the caregiver's anxiety level
Délai: 3 months and 6 months after randomization
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Evolution of the caregiver's anxiety level estimated with repeated measures with the Spielberger's State-Trait Anxiety Inventory (STAI Y-A / Y-B).
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3 months and 6 months after randomization
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Evolution of the caregiver's depressive symptomatology
Délai: 3 months and 6 months after randomization
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Evolution of the caregiver's depressive symptomatology estimated with repeated measures of the Beck Depression Inventory (BDI)
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3 months and 6 months after randomization
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Evolution of the caregiver's quality of life
Délai: 3 months and 6 months after randomization
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Evolution of the caregiver's quality of life estimated with repeated measures of the Quality of Life in Alzheilmer's Disease scale, caregiver version
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3 months and 6 months after randomization
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Evolution of the patient's quality of life
Délai: 3 months and 6 months after randomization
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Evolution of patient's quality of life estimated with repeated measures of the Quality of Life in Alzheilmer's Disease scale, patient version
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3 months and 6 months after randomization
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Evolution of the patient's independence
Délai: 3 months and 6 months after randomization
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Evolution of the patient's independence with repeated measures of the Instrumental Activities of Daily Life (IADL-E, 9 items).
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3 months and 6 months after randomization
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Evolution of the caregiver's quality of life
Délai: 3 months and 6 months after randomization
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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).
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3 months and 6 months after randomization
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Evolution of the patient's quality of life
Délai: 3 months and 6 months after randomization
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Evolution of patient's quality of life estimated with repeated measures of the Quality of Life with EQ-5D questionnaire (EuroQol Five Dimensions questionnaire).
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3 months and 6 months after randomization
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Number of falls
Délai: 1 months, 3 months and 6 months after randomization
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Number of times the patient has fallen after 1 month, 3 months and 6 months.
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1 months, 3 months and 6 months after randomization
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Number of run aways
Délai: 1 months, 3 months and 6 months after randomization
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Number of times the patient has ran away after 1 month, 3 months and 6 months.
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1 months, 3 months and 6 months after randomization
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Number of drugs prescribed to the caregiver and the patient
Délai: at inclusion and at 6 months
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Evolution of the number of drugs prescribed to the caregiver and the patient at inclusion and after 6 months of follow-up.
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at inclusion and at 6 months
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Indirect medical costs and direct non-medical costs
Délai: 6 months
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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
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6 months
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Evaluation of the caregiver's adherence to the Lili Smart solution
Délai: 7 months
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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).
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7 months
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Evaluation of patient's adherence to the Lili Smart solution
Délai: 7 months
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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).
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7 months
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Caregiver's burden evolution
Délai: 3 months after randomization
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Natural caregiver's burden evolution after 3 months of follow-up.
Assessement with the Zarit scale
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3 months after randomization
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Pierre Krolak-Salmon, MD, Hospices Civils de Lyon
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 69HCL16_0706
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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