An interventional study of Functionalities of the Lili Smart Solution activated and Functionalities of the Lili Smart Solution non activated in Alzheimer Disease, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-03-13.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Prevention
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Among 16 studies in Alzheimer Disease by Hospices Civils de Lyon — 5 open to participants now, 5 under way, none of them phase 3. Alzheimer Disease · Hospices Civils de Lyon.
Among the 16 studies in Alzheimer Disease by Hospices Civils de Lyon, this one is the 9th largest by planned enrollment of the 13 interventional ones that give a count, is the only one that started in 2018, is one of 13 with no phase, and was the 11th registered.
3,967 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →5 of the 16 studies in Alzheimer Disease by Hospices Civils de Lyon are open now, in 1 country. Recruiting first, the newest first:
Hospices Civils de Lyon · Sites in France
Ages 60+
Hospices Civils de Lyon · Sites in France
Ages 55+
Hospices Civils de Lyon · Sites in France
Ages 65+
Hospices Civils de Lyon · Sites in France
Ages 50–90 · Healthy volunteers
Hospices Civils de Lyon · Sites in France
Ages 20–85 · Healthy volunteers
By country, each count listing its studies:
Of the 642 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 284 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
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16 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2018.
This study's planned enrollment of 60 is below the median of 70 across 3,020 interventional studies indexed under Alzheimer Disease.
Median enrollment 240 across the 13 interventional studies, 312 across the 3 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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Hospices Civils de Lyon is the lead sponsor of 1,867 studies on the registry; 448 are open to participants now.
2 of the studies in Alzheimer Disease by Hospices Civils de Lyon that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02800395Hospices Civils de LyonInfluence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease | 2026-12 |
| NCT02302482Hospices Civils de LyonPredictive Factors and Autonomy Level Change | 2027-11 |
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Among the 16 studies in Alzheimer Disease by Hospices Civils de Lyon, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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 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:
In addition to the social impact measurement, the study aims to demonstrate the medico-economic impact of Lili smart solution as follow:
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).
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Caregiver inclusion's criteria :
Patient Inclusion Criteria:
Exclusion Criteria:
Patients exclusion's criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
Time frame: 6 months after randomization
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).
Time frame: 3 months and 6 months after randomization
Evolution of the caregiver's depressive symptomatology
Evolution of the caregiver's depressive symptomatology estimated with repeated measures of the Beck Depression Inventory (BDI)
Time frame: 3 months and 6 months after randomization
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
Time frame: 3 months and 6 months after randomization
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
Time frame: 3 months and 6 months after randomization
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).
Time frame: 3 months and 6 months after randomization
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).
Time frame: 3 months and 6 months after randomization
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).
Time frame: 3 months and 6 months after randomization
Number of falls
Number of times the patient has fallen after 1 month, 3 months and 6 months.
Time frame: 1 months, 3 months and 6 months after randomization
Number of run aways
Number of times the patient has ran away after 1 month, 3 months and 6 months.
Time frame: 1 months, 3 months and 6 months after randomization
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.
Time frame: at inclusion and at 6 months
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
Time frame: 6 months
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).
Time frame: 7 months
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).
Time frame: 7 months
Caregiver's burden evolution
Natural caregiver's burden evolution after 3 months of follow-up. Assessement with the Zarit scale
Time frame: 3 months after randomization
Started Feb 2018 (actual). Primary completion is estimated for Sep 2019, 19 months after the start.
Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 19 months is below that.
Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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