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| Name | Class |
|---|---|
| Clinical Research Units Hungary | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DRT Users | Single observational cohort exposed to a personalized digital reminiscence therapy, through daily 10-15 minute sessions. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, Day 25, Day 50. |
| 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). | Baseline, Day 25, Day 50. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 25, Day 50. |
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Inclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter MARKUS | Contact | +36303621811 | peter@kompanioncare.com |
| Name | Affiliation | Role |
|---|---|---|
| Cédric Annweiler, Geriatrician, PhD neuroscience | Angers University Hospital Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers, Service médecine gériatrique. | Recruiting | Angers | 49 933 | France |
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| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D060825 | Cognitive Dysfunction |
| D053609 | Lethargy |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| 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. | Baseline, Day 25, Day 50. |
| 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 | From Baseline to Day 25 |
| 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 | From Baseline to Day 25. |
| Limoges University Hospital Center - Dupuytren Hospital], Geriatric medicine department | Recruiting | Limoges | 87042 | France |
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| Centre Hospitalier Universitaire de Nice - Institut Claude Pompidou, Centre Mémoire de Ressources et de Recherches (CM2R) | Recruiting | Nice | 06100 | France |
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| APHP Hôpitaux universitaires Paris centre. | Not yet recruiting | Paris | 75013 | France |
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| CHU DE TOURS, Pôle Vieillissement, Hôpital Bretonneau. | Recruiting | Tours | 37044 | France |
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |