Идёт набор NCT07499570

Multi-modal Large Language Model-Empowered Talk Therapy for Older Adults With ADRD

Без фазы С лечением Mild Cognitive Impairment Dementia BPSD BPSD (Behavioral and Psychological Symptoms of Dementia)

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: В протоколе указаны: Smart Virtual Reminiscence Therapy, Music Therapy.
Кому может быть актуально: Состояния в реестре: Mild Cognitive Impairment, Dementia, BPSD, BPSD (Behavioral and Psychological Symptoms of Dementia). Базовые параметры: от 65 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: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The purpose of this study is to test the usefulness and the effect of Smart Virtual Reminiscence (SVR) therapy intervention on the Behavioral and Psychological Symptoms of Dementia (BPSD) of patients with Alzheimer's Disease and Related Dementias (ADRD). SVR is designed to help older adults improve their psychological well-being and cognition. This research supports our long-term goal of designing and implementing intelligent interactive systems to improve the health of individuals with ADRD.

Подробное описание

Nonpharmacological approaches, such as Reminiscence Therapy (RT), have been a major investigation for ADRD in recent years, but lack of human facilitators, lack of training, technology adaptation, and lack of multi-sensory features are major implementation barriers. In addition, a good RT requires utilizing the personal life experiences of patients as topics of sharing, while showing concrete objects such as photographs, videos, and music that are memorable to the individuals. However, older adults may have a hard time collecting these materials for themselves.

To address these limitations, the researchers have developed a novel SVR that is delivered through a computer program that can be accessed using a personal computer or smart device, and includes new functions so that there is no need for a human therapist to facilitate the RT sessions, and so that older adults and care partners do not need to collect reminiscence materials in advance. SVR presents a virtual therapist (avatar) who interacts with older adults through verbal (speech) and non-verbal communication (eye gaze, body language, etc.), understands the user's speech, and guides the user through reminiscence sessions.

In this study, patient/caregiver dyads will be randomized to receive SVR intervention or an attention control intervention (listening to music). Participants randomized to SVR will either visit the study site (accompanied by the caregiver) to complete SVR sessions or complete the sessions at home, up to twice a week for 12 weeks. Participants randomized to the control arm will receive a curated playlist of calming music, accessible online, that they need to listen to twice a week for 12 weeks. Patient BPSD will be collected at baseline and monthly for 3 months.

Вмешательства

Устройство Smart Virtual Reminiscence Therapy
SVR Therapy is delivered through a computer program that can be accessed using a personal computer or smart device. It uses virtual reality, automated speech recognition, and large language models to achieve virtual therapist-patient interaction. The SVR therapy platform also automatically sources multi-modal reminiscence materials (e.g., images, text, etc.) through search engines and databases to facilitate the reminiscence therapy sessions. Each participant will participate in two 25-60 min (
Другое Music Therapy
Participants in the attention control group will receive a curated playlist of calming music that they need to listen to twice a week for 12 weeks. The music can be conveniently accessed online (e.g., through YouTube).

Первичные конечные точки

Reduction in BPSD as measured by the Neuropsychiatric Inventory (NPI) total score [Срок оценки: Baseline and Month 3]
Rate of all-cause hospitalizations and emergency visits during the study period [Срок оценки: Baseline through study completion, approximately 3 months]

Критерии участия

For the patient:

Критерии включения

age ≥ 65 years
diagnosis of MCI (mild cognitive impairment) or mild ADRD
access to a reliable internet connection
community-dwelling
elevated behavioral and psychological symptoms of dementia (BPSD), indicated by a HABC (Healthy Aging Brain Care) monitor score above 14 on caregiver report or self report (indicating elevated levels of BPSD)
presence of one or more specific BPSD behaviors (e.g., agitation, anxiety, depression, apathy, or sleep disturbances)
ability to consent for themselves.

Критерии исключения

lives in an assisted living facility or nursing home
has moderate to severe ADRD as measured by the Quick Dementia Rating System
has a life expectancy of less than 6 months.

For the care partner:

Критерии включения

≥ 21 years old
self-identified care partner (e.g., is knowledgeable about the patient's daytime and nighttime behaviors) of a community-dwelling patient diagnosed with MCI or mild ADRD who will also participate in the study