Effects of Personalized Reminiscence Sessions Delivered by a Digital Conversational Agent to Patients With Neurocognitive Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
This study aims to observe the effects of daily personalized digital reminiscence sessions, conducted with the help of a digital conversational agent, and to determine whether these sessions lead to improvements in symptoms such as apathy and depression.
The researchers therefore seek to observe whether this daily use can improve certain aspects of well-being, such as motivation, mood, sleep quality, quality of life, and engagement with the tool.
The study also aims to assess whether simple reminders delivered via the application are sufficient to encourage regular use without external assistance.
Participants will:
- Use the reminiscence app for 25 days for 10-15 minutes.
- Have a primary caregiver help personalize the app by sharing family memories, other relatives may optionally contribute in a private group.
- Complete brief questionnaires at the start and during follow-up routine visits (for example, apathy and depression scales, sleep, and quality of life).
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
- •Men and women over 60 years of age.
- •DSM-5 diagnosis: Early stage of major neurocognitive disorders or MCI (Mild Cognitive Impairment) including all underlying causes.
- •Have a Mini-Mental State Exam score of 21 ≤ MMSE ≤
- •Presence of mild or moderate depression, or presence of mild or moderate apathy, or presence of both
- •Displays the necessary physical and cognitive abilities, without major limitations compromising interaction with the digital tool.
- •Having voluntarily and informedly agreed to participate in the study (signed written consent).
- •Subject's ability to hear and see the digital tool's stimuli (tests integrated into the tool).
- •Patients with access to an Apple device (smartphone or tablet), either personal or provided by the sponsor, running iOS version 16 or higher, with internet access.
- •Patient has at least one close referent who declares their wish to contribute to the collection of biographical information via the digital messaging group.
- •Subjects covered by a social security scheme.
排除标准
- •Patients with moderate or severe dementia (MMSE score ≤ 20) because implicit memory recall is less effective in moderate or severe stages for people with PWD.
- •Presence of major psychiatric disorders (e.g., schizophrenia, severe major depressive episode, bipolar disorder).
- •Major hearing or visual impairments.
- •History of premorbid intellectual disability.
- •Patients under guardianship, conservatorship, or legal protection.
- •Patients who have already used the Lilia app
- •Participating simultaneously in another study involving human subjects, a clinical investigation, or a therapeutic trial for the entire duration of the study.
- •Patients who have received a new treatment related to neurocognitive disorders (medication) during the 3 months prior to the inclusion visit.
研究组 & 干预措施
DRT Users
Single observational cohort exposed to a personalized digital reminiscence therapy, through daily 10-15 minute sessions.
结局指标
主要结局
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
时间窗: Baseline, Day 25, Day 50.
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated scale of depressive symptom severity. Possible scores range from 0 to 60, with higher scores indicating more severe depression. Decrease of MADRS total score between two measurement points indicates improvement over time. Unit of Measure: points (from 0 to 60)
Change in Lille Apathy Rating Scale (LARS) Total Score
时间窗: Baseline, Day 25, Day 50.
The Lille Apathy Rating Scale (LARS) is a clinician-rated questionnaire assessing apathy with a total score from -36 to +36. Higher scores indicating greater apathy. Decrease of LARS total score between two measurement points indicates improvement over time. Unit of Measure: points (from -36 to +36).
次要结局
- Change in Pittsburgh Sleep Quality Index (PSQI) Global Score(Baseline, Day 25, Day 50.)
- Number of Sessions Completed(From Baseline to Day 25)
- Change in The Short Form Survey (SF-36) Global Score.(Baseline, Day 25, Day 50.)
- Average Self-Reported Session Duration(From Baseline to Day 25.)