Lili Smart Study - Connected Solution of Assistance Dedicated to Caregivers and People With Alzheimer's Disease or Related Diseases
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Caregiver's burden evolution
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients exclusion's criteria:
- •Known psychiatric disorders
- •Disabling motor and / or sensory impairment
- •Patient under guardianship
研究组 & 干预措施
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.
干预措施: Functionalities of the Lili Smart Solution activated (Other)
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.
干预措施: Functionalities of the Lili Smart Solution non activated (Other)
结局指标
主要结局
Caregiver's burden evolution
时间窗: 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
次要结局
- Number of run aways(1 months, 3 months and 6 months after randomization)
- Caregiver's burden evolution(3 months after randomization)
- Evolution of the caregiver's depressive symptomatology(3 months and 6 months after randomization)
- Evaluation of patient's adherence to the Lili Smart solution(7 months)
- Evolution of the caregiver's anxiety level(3 months and 6 months after randomization)
- Indirect medical costs and direct non-medical costs(6 months)
- Evaluation of the caregiver's adherence to the Lili Smart solution(7 months)
- Evolution of the patient's independence(3 months and 6 months after randomization)
- Number of falls(1 months, 3 months and 6 months after randomization)
- Number of drugs prescribed to the caregiver and the patient(at inclusion and at 6 months)
- Evolution of the caregiver's quality of life(3 months and 6 months after randomization)
- Evolution of the patient's quality of life(3 months and 6 months after randomization)