Effects of Personalized Digital Reminiscence Therapy on Patients With Neurocognitive Disorders
Recruiting · NCT07237009 · Observational (researchers observe without assigning treatment) · Lead sponsor: KompanionCare SAS
View the official record on ClinicalTrials.gov →What this trial is about
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).
Who can take part
Inclusion criteria
- 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
- 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.
Exclusion criteria
- 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.
Where it is running
5 locations listed.
- CHU Angers, Service médecine gériatrique. - Angers, France
- Limoges University Hospital Center - Dupuytren Hospital], Geriatric medicine department - Limoges, France
- Centre Hospitalier Universitaire de Nice - Institut Claude Pompidou, Centre Mémoire de Ressources et de Recherches (CM2R) - Nice, France
- APHP Hôpitaux universitaires Paris centre. - Paris, France
- CHU DE TOURS, Pôle Vieillissement, Hôpital Bretonneau. - Tours, France