Assessment of Changes in Autonomy Through Analysis of Smartphone Usage Data in Patients With Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Comparison of changes in smartphone usage data and battery life collected at 0 and 18 months
研究概览
简要总结
Alzheimer's disease is the leading cause of dementia worldwide. The first cognitive function to be affected is memory. As the disease progresses, other cognitive systems are affected, leading to a gradual loss of independence for the patient. This loss of independence is at the heart of the psychosocial and medico-economic challenges posed by Alzheimer's disease. Functional independence refers to the patient's ability to perform activities of daily living. The evolution of autonomy varies significantly from one individual to another, and a specific, personalized assessment is necessary in order to offer appropriate care and services. There is a link between patient autonomy and psycho-behavioral disorders. Early identification of loss of autonomy in connection with psycho-behavioral disorders would allow specific treatment to be put in place.
The study hypothesis is that there is a link between changes in smartphone data and changes in the independence of patients with AD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •Patient consulting on routine care at a memory resource and research center for Alzheimer's disease defined by cognitive memory complaints from the patient or their family and friends, evidence of impaired verbal episodic memory storage in FCSRT defined by a sum of FR values less than 17/48 and a sum of CR values less than 40/48 compared to the patient's age and socio-cultural level and no criteria on other neuropsychological tests, progressive decline over at least 6 months affecting independence, and if a brain MRI, a lumbar puncture, and/or an 18FDG PET scan were performed as part of the patient's routine care, the results must be consistent with a diagnosis of MA.
- •Patient with a smartphone for their exclusive use that is compatible with the installation of the IMASMART application on Android
- •No sensory impairment (vision or hearing impairment) that could compromise the use of a smartphone
- •Absence of major anxiety-depressive disorder defined by a HAD score > 16
- •Patient an caregiver not objecting to participating in the study
排除标准
- •Inability to perform the Mini-Mental State Examination or score < 17
- •Other neurodegenerative disorders
- •Severe, unstable psychiatric disorders
- •Terminal phase of a severe illness
- •Other conditions that may compromise the use of a smartphone
- •Patients with an iPhone
- •MRI evidence of a lesion that may contribute to cognitive impairment (stroke, tumors, etc.)
- •Refusal to install the application
- •People residing in a residential care for senior or any other medical facility
- •Individuals benefiting from enhanced protection, namely individuals deprived of their liberty by judicial or administrative decision, adults under legal protection, and finally, patients in emergency situations.
研究组 & 干预措施
Alzheimer's patients
干预措施: Data collection (Other)
Alzheimer's patients
干预措施: Neuropsychological assesment (Other)
Alzheimer's patients
干预措施: Autonomy questionnaire (Other)
结局指标
主要结局
Comparison of changes in smartphone usage data and battery life collected at 0 and 18 months
时间窗: From enrollment to the end of participation at 18 months
To measure the relationship between variations in smartphone usage data-represented as a single parameter created through a mathematical combination-and variations in the Amsterdam IADL questionnaire between 0 and 18 months.
次要结局
未报告次要终点