A Large Language Model-Driven Daily Conversation Cognitive Interaction Platform: Feasibility and Preliminary Efficacy in Older Adults at High Risk of Dementia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 主要终点
- Verbal fluency test
研究概览
简要总结
This study will develop and test a daily conversation platform that uses a large language model, a type of artificial intelligence, to support cognitive health in older adults at high risk of dementia.
The platform will guide participants through voice-based conversations about topics that interest them. The conversations are designed to engage memory, attention, language, planning and problem-solving, and the ability to understand social situations. The platform will also analyze conversation data and create a report describing the participant's cognitive performance.
The study has two stages. In the first stage, 15 participants will test the platform through two 20-minute conversation sessions. This group will include healthy younger adults, older adults with normal cognitive function, and older adults with cognitive difficulties. Participants will provide feedback on how easy and acceptable the platform is to use.
In the second stage, 60 older adults at high risk of dementia will be randomly assigned to one of three groups. The groups will receive either conversation-based cognitive activities using the platform, interest-based news reading activities, or weekly health education while waiting to receive the intervention. The study activities will continue for 12 weeks. Researchers will compare changes in cognitive function, emotional well-being, loneliness, social connection, and user experience before and after the study.
The main goals are to learn whether the platform is practical and acceptable for home use and whether it may help support cognitive and psychosocial health.
详细描述
Cognitive decline is an important health concern in aging populations. Early cognitive stimulation that is meaningful and related to daily life may help older adults maintain cognitive and psychosocial function. However, many digital cognitive programs use repetitive exercises and provide limited opportunities for natural social interaction.
This study aims to develop and evaluate a large language model-driven daily conversation cognitive interaction platform for older adults at high risk of dementia. The platform uses voice-based, semi-structured conversations based on topics that interest each participant. The conversations are designed to stimulate five cognitive areas: memory, attention, language, executive function, and social cognition.
During each session, participants speak with the platform using natural conversation. The system converts speech into text and analyzes selected features of the participant's responses, such as response accuracy, language fluency, organization of ideas, attention to the conversation, and understanding of social situations. The system then generates a cognitive profile report. This report is intended to provide understandable information about performance across the five cognitive areas and is not intended to diagnose dementia.
The study will be conducted in two stages.
Stage 1 will evaluate the initial feasibility and usability of the platform. Fifteen participants will be enrolled, including five healthy younger adults, five older adults with normal cognitive function, and five older adults with cognitive difficulties. Each participant will complete two 20-minute conversation sessions. Participants will then complete questionnaires about system usability and intervention acceptability. Their comments and experiences will be used to improve the platform before the randomized trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stage 1: Feasibility Study
- •Participants must belong to one of the following groups:
- •Healthy younger adults aged 18 to 40 years. Older adults with normal cognitive function aged 65 years or older and a Montreal Cognitive Assessment score of 24 or higher.
- •Older adults with cognitive impairment aged 65 years or older and a Montreal Cognitive Assessment score of 18 to
- •Participants must have completed at least elementary school, corresponding to 6 or more years of education.
- •Participants must be able to read and write Chinese, communicate in Chinese, and understand the study content.
- •Participants must be able to use a tablet or smartphone independently or with assistance from a family member.
- •Participants must have sufficient hearing and vision, with usual corrective devices if needed, to complete the study tasks.
- •Stage 2: Preliminary Efficacy Study
- •Participants must be aged 65 years or older.
- •Participants must be considered at high risk of dementia by meeting at least one of the following conditions:
- •Subjective cognitive decline:
- •A Subjective Cognitive Decline Questionnaire score greater than 7 out of
- •A response of yes to both of the following questions:
- •Compared with your previous usual condition, do you have memory problems? Have your family members or close contacts noticed memory problems compared with your previous condition? Performance within the normal range on standardized cognitive tests, defined as scores no more than 1.5 standard deviations below age- and education-adjusted norms on the Color Trails Test and memory-related assessments.
- •Mild cognitive impairment:
- •A diagnosis of mild cognitive impairment made by a neurologist or psychiatrist according to accepted diagnostic criteria.
- •Evidence of memory performance at least 1.5 standard deviations below age- and education-adjusted normative values on at least one subtest of the Wechsler Memory Scale, Third Edition.
- •Limited social interaction:
- •Living alone, living with a person who cannot provide care, or living with a person who is absent for at least 3 days per week; or A score below 12 on the 6-item Lubben Social Network Scale.
- •Chronic disease:
- •A physician diagnosis of hypertension or diabetes for at least 1 year; and A need for ongoing medication or lifestyle management. Participants must have completed at least elementary school, corresponding to 6 or more years of education.
- •Participants must be able to read and write Chinese, communicate in Chinese, and understand news and study-related content.
- •Participants must be able to use a tablet or smartphone independently or with assistance from a family member.
- •Participants must have sufficient hearing and vision, with usual corrective devices if needed, to complete the conversation and reading tasks.
排除标准
- •A diagnosis of dementia or a severe neurodegenerative disorder, such as moderate-to-advanced Parkinson disease or Huntington disease.
- •A history of a severe psychiatric disorder, such as schizophrenia or severe bipolar disorder, or current acute psychiatric symptoms that may interfere with understanding or responding during conversations.
- •A major neurological event within the previous 6 months, such as stroke or severe traumatic brain injury, that may substantially affect cognitive or language function.
- •Severe hearing, speech, or language impairment that prevents basic verbal communication, even when assistive devices are used.
- •An acute medical illness, active infection, or any condition considered by a physician to make study participation inappropriate.
- •Inability to complete a 20-minute conversation task or unwillingness to allow collection of interaction data.
研究组 & 干预措施
LLM Conversation Cognitive Interaction
Participants will complete a 12-week, home-based cognitive intervention using a large language model-driven conversation platform. They will use the platform five times per week for approximately 20 minutes per session.
The platform will begin each session with a brief conversation about the participant's recent experiences. Participants will then select a topic based on their interests and discuss a short topic summary with the platform. The conversations will include activities designed to engage memory, attention, language, executive function, and social cognition. The platform will adjust the depth of questions and follow-up prompts based on the participant's responses.
Research staff will provide two initial in-person training sessions and weekly video-call follow-up. Technical support and adherence reminders will be provided through the LINE platform.
干预措施: LLM Conversation Cognitive Interaction (Behavioral)
Interest-Based Knowledge Reading
Participants will complete a 12-week, home-based reading intervention using an interest-based knowledge reading platform. They will use the platform five times per week for approximately 20 minutes per session.
During each session, participants will briefly report on their recent experiences and select topics based on their interests. The platform will provide four short news summaries, including familiar and unfamiliar topics and both preferred and non-preferred topics. Participants will answer five multiple-choice questions after each summary to support attention and understanding of the content.
Research staff will provide two initial in-person training sessions and weekly video-call follow-up. Technical support and adherence reminders will be provided through the LINE platform.
干预措施: Interest-Based Knowledge Reading (Behavioral)
Waitlist Health Education
Participants will receive general health education materials once per week for 12 weeks through the LINE platform. They will not receive the conversation or reading intervention during the initial 12-week study period.
After completing the post-intervention assessments, participants will be offered an opportunity to receive one of the two cognitive interventions. Their later intervention assignment will not be included in the primary comparison of the randomized trial.
干预措施: Waitlist Health Education (Behavioral)
结局指标
主要结局
Verbal fluency test
时间窗: Change from Baseline at 13 weeks
The Verbal Fluency Test assesses language production and executive function. Participants will name as many items as possible from specified semantic categories, including fruits and vegetables, within 60 seconds. The outcome is the number of correct, non-repeated words produced. Higher scores indicate better verbal fluency. The primary outcome will be the change in the total number of correct words from baseline to the post-intervention assessment.
Chinese Verbal Learning Test
时间窗: Change from Baseline at 13 weeks
The Chinese Version Verbal Learning Test assesses verbal learning and memory. A list of 9 two-character nouns is presented across 4 learning trials. After each trial, participants recall as many words as possible. One point is given for each correctly recalled word. The total learning score is the sum of correct responses across the 4 learning trials and ranges from 0 to 36. Higher scores indicate better verbal learning. The primary outcome will be the change in the total learning score from baseline to the post-intervention assessment.
次要结局
- Digit Span subtest(Change from Baseline at 13 weeks)
- Cookie Theft Picture(Change from Baseline at 13 weeks)
- Digit Symbol Substitution Test(Change from Baseline at 13 weeks)
- Stroop Color and Word Test(Change from Baseline at 13 weeks)
- Color Trails Test(Change from Baseline at 13 weeks)
- Theory of Mind Scale(Change from Baseline at 13 weeks)
- Geriatric Depression Scale- 15(Change from Baseline at 13 weeks)
- University of California, Los Angeles, Loneliness Scale(Change from Baseline at 13 weeks)
- Chinese Happiness Inventory(Change from Baseline at 13 weeks)
- Visual Analogue Scale of Subjective Cognitive Function(Change from Baseline at 13 weeks)
- System Usability Scale(Within 1 week after completion of the 12-week intervention (Week 13))
- Acceptability of Intervention Measure(Within 1 week after completion of the 12-week intervention (Week 13))