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临床试验/NCT07499570
NCT07499570招募中不适用

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

Indiana University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Reduction in BPSD as measured by the Neuropsychiatric Inventory (NPI) total score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • For the patient:
  • Inclusion criteria:
  • 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.

排除标准

  • 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:
  • Inclusion criteria:
  • ≥ 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
  • Exclusion criteria:
  • has MCI or dementia
  • has a severe mental illness or substance abuse
  • has a life expectancy of less than 6 months.

研究组 & 干预措施

Patient Music Therapy

Active Comparator

Patient listens to Youtube playlist

干预措施: Music Therapy (Other)

Smart Virtual Reminiscence Therapy

Experimental

Patient uses Smart Virtual Reminiscence Therapy

干预措施: Smart Virtual Reminiscence Therapy (Device)

结局指标

主要结局

Reduction in BPSD as measured by the Neuropsychiatric Inventory (NPI) total score

时间窗: Baseline and Month 3

Caregivers assess multiple (12) behavior domains for the patient. For each behavior that is present, behavior frequency and severity are rated. Frequency is rated on a 4 point scale, with 1 indicating rare behavior and 4 indicating very frequent behavior. Severity is rated on a 3 point scale, with 1 indicating mild behavior and 3 indicating severe behavior. The product of frequency multiplied by severity equals the total domain score for each behavior. Total domain scores are then summed to obtain the NPI total score. NPI total scores can range from 0 to 144, with higher scores indicating more frequent and severe behaviors overall.

Rate of all-cause hospitalizations and emergency visits during the study period

时间窗: Baseline through study completion, approximately 3 months

These data will be collected and used to assess whether a reduction in BPSD may lead to fewer crisis events requiring acute medical care.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

MALAZ BOUSTANI

Professor

Indiana University

研究点 (1)

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