About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 ≤ 28.
Presence of mild or moderate depression, or presence of mild or moderate apathy, or presence of both
Disqualifiers
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.
Trial population
Participants will be recruited during routine visits at five French university hospital geriatrics/memory clinics. The source population comprises older adults followed in these services who live mainly at home or in hospital-based residential settings. The study focuses exclusively on patients with mild neurocognitive disorder or mild dementia, and includes individuals with mild depression.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
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
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).
Secondary outcomes
Change in The Short Form Survey (SF-36) Global Score.
The Short Form Survey (SF-36) measures health-related quality of life. Scores range from 0 to 100, with higher scores indicating better health status. Increase of SF-36 global score between two measurement points indicates improvement over time. Unit of Measure: Points on SF-36 scale from 0 to 100.
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score
The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire evaluating sleep quality with scores from 0 to 21, with higher scores indicating worse sleep quality. Decrease of PSQI global score between two measurement points indicates improvement over time. Unit of Measure: Points on PSQI scale from 0 to 21.
Number of Sessions Completed
Counting the number of sessions completed by the patient between Baseline and Day 25. Higher numbers are indicating greater adherence to the application use. Unit of Measure: Number of Sessions Completed
Average Self-Reported Session Duration
Average self-reported session duration is the approximate average time spent per session with using the Lilia application between Baseline and Day 25 based on the patients' own observations. It is measured by a dedicated question: "On average, how much time did you spend with Lilia when you used it?" (response options: "Less than 5 minutes," "5-10 minutes," "More than 10 minutes"). Higher values refers to longer average sessions. Unit of Measure: average minutes per session
Sponsors and contacts
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KompanionCare SAS
Lead sponsor
Clinical Research Units Hungary
Collaborator