Alzheimer DiseaseLili smartNCT03295110
Connected Solution of Assistance Dedicated to Caregivers and People With Alzheimer's Disease or Related Diseases
A study testing Functionalities of the Lili Smart Solution activated and Functionalities of the Lili Smart Solution non activated in people with Alzheimer Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Functionalities of the Lili Smart Solution activated and Functionalities of the Lili Smart Solution non activated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2018to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- Patients exclusion's criteria:
- Known psychiatric disorders
- Disabling motor and / or sensory impairment
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital des Charpennes
Villeurbanne, 69100
Pierre Krolak Salmon, Pr
About this study
Official title: 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".
Read more
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.
Read the detailed description
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).
- Conditions
- Alzheimer Disease
- Being tested
- Functionalities of the Lili Smart Solution activated, Functionalities of the Lili Smart Solution non activated
- Keywords
- Alzheimer's disease and Related Disorders (ADRD), natural caregiver, non-medical connected device, caregiver's burden, anxiety, costs, quality of life, depressive symptoms, independence
- Medical subject headings
- Alzheimer Disease, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functionalities of the Lili Smart Solution activatedOther
Also called Non-medical connected device (Lili Smart solution) with active functionalities
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.
Functionalities of the Lili Smart Solution non activatedOther
Also called Non-medical connected device (Lili Smart solution) with inactive 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Functionalities of the Lili Smart Solution non activated |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after randomization
Secondary outcomes (14)
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).
Measured: 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)
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 7 months
Caregiver's burden evolution
Natural caregiver's burden evolution after 3 months of follow-up. Assessement with the Zarit scale
Measured: 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start13 Feb 2018
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Lili smart
- Responsible party
- Sponsor
- Investigators
- Pierre Krolak-Salmon, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295110
- Sponsor's protocol ID
- 69HCL16_0706
- Acronym
- Lili smart
- Status last verified
- Sep 2017
- First submitted
- 12 Sep 2017
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lili Smart Study - Connected Solution of Assistance Dedicated to Caregivers and People With Alzheimer's Disease or Related Diseases
- ClinicalTrials.gov ID
- NCT03295110
- Acronym / sponsor ID
- Lili smart / 69HCL16_0706
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's disease and Related Disorders (ADRD), natural caregiver, non-medical connected device, caregiver's burden, anxiety, costs, quality of life, depressive symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Lili smart
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 27 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functionalities of the Lili Smart Solution activated | Experimental | Other: Functionalities of the Lili Smart Solution activatedLili 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. |
| Functionalities of the Lili Smart Solution non activated | Other | Other: Functionalities of the Lili Smart Solution non activatedLili Smart watch worn by the participants and sensors placed at home with their functionalities inactivated. Absence of the web / mobile application. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (4 listed)
- Known psychiatric disorders
- Disabling motor and / or sensory impairment
- Patient under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functionalities of the Lili Smart Solution activatedAlso: Non-medical connected device (Lili Smart solution) with active functionalitiesNon-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. | Other | Functionalities of the Lili Smart Solution activated |
| Functionalities of the Lili Smart Solution non activatedAlso: Non-medical connected device (Lili Smart solution) with inactive functionalitiesNon-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. | Other | Functionalities of the Lili Smart Solution non activated |
Primary outcome
Caregiver's burden evolution
Time frame: 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
14 secondary outcomes
Evolution of the caregiver's anxiety level
Time frame: 3 months and 6 months after randomization
Evolution of the caregiver's depressive symptomatology
Time frame: 3 months and 6 months after randomization
Evolution of the caregiver's quality of life
Time frame: 3 months and 6 months after randomization
Evolution of the patient's quality of life
Time frame: 3 months and 6 months after randomization
Evolution of the patient's independence
Time frame: 3 months and 6 months after randomization
Evolution of the caregiver's quality of life
Time frame: 3 months and 6 months after randomization
Evolution of the patient's quality of life
Time frame: 3 months and 6 months after randomization
Number of falls
Time frame: 1 months, 3 months and 6 months after randomization
Number of run aways
Time frame: 1 months, 3 months and 6 months after randomization
Number of drugs prescribed to the caregiver and the patient
Time frame: at inclusion and at 6 months
Indirect medical costs and direct non-medical costs
Time frame: 6 months
Evaluation of the caregiver's adherence to the Lili Smart solution
Time frame: 7 months
Evaluation of patient's adherence to the Lili Smart solution
Time frame: 7 months
Caregiver's burden evolution
Time frame: 3 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Krolak-Salmon, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functionalities of the Lili Smart Solution activated and Functionalities of the Lili Smart Solution non activated in people with Alzheimer Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deborah Viricel (4 72 43 25 01 ext. +33, deborah.viricel@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver's burden evolution (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.