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Идёт набор NCT07237009

Effects of Personalized Digital Reminiscence Therapy on Patients With Neurocognitive Disorders

— Наблюдательное Neurocognitive Disorders, Mild Cognitive Impairment, Mild Depression Mild Apathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Neurocognitive Disorders, Mild, Cognitive Impairment, Mild, Depression Mild, Apathy. Базовые параметры: от 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

Effects of Personalized Reminiscence Sessions Delivered by a Digital Conversational Agent to Patients With Neurocognitive Disorders

Обзор

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).

Первичные конечные точки

  • Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score [Срок оценки: Baseline, Day 25, Day 50.]
  • Change in Lille Apathy Rating Scale (LARS) Total Score [Срок оценки: Baseline, Day 25, Day 50.]
Вторичные конечные точки (4)
  • Change in The Short Form Survey (SF-36) Global Score. [Срок оценки: Baseline, Day 25, Day 50.]
  • Change in Pittsburgh Sleep Quality Index (PSQI) Global Score [Срок оценки: Baseline, Day 25, Day 50.]
  • Number of Sessions Completed [Срок оценки: From Baseline to Day 25]
  • Average Self-Reported Session Duration [Срок оценки: From Baseline to Day 25.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 5 центров
  • CHU Angers, Service médecine gériatrique. — Angers
  • Limoges University Hospital Center - Dupuytren Hospital], Geriatric medicine department — Limoges
  • Centre Hospitalier Universitaire de Nice - Institut Claude Pompidou, Centre Mémoire de Res — Nice
  • APHP Hôpitaux universitaires Paris centre. — Paris
  • CHU DE TOURS, Pôle Vieillissement, Hôpital Bretonneau. — Tours

Идентификаторы

NCT: NCT07237009 · 2025-A01382-47_PROTOCOLE_v3.0

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗