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AI-CONECT: A Conversational AI for Early Dementia Prevention in Socially-Isolated Older Adults (AI-CONECT)

2026年8月22日 更新者：Hiroko Hayama Dodge、Massachusetts General Hospital

AI-CONECT: A Conversational AI for Early Dementia Prevention in Socially-Isolated Older Adults Based on the Efficacy-Proven I-CONECT Study

This randomized controlled trial examines the mechanisms of conversational AI-based interventions for early dementia prevention in socially isolated older adults.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Social isolation is a well-established and modifiable risk factor for cognitive decline and dementia. The completed I-CONECT trial (NCT02871921) showed that frequent, one-to-one, semi-structured conversational engagement delivered remotely by trained human interviewers improved cognitive outcomes among socially isolated older adults with mild cognitive impairment. Two limitations have constrained translating that approach into a scalable preventive intervention: its reliance on trained human interviewers limits scalability, and the behavioral mechanisms responsible for its cognitive benefits remain incompletely understood.

AI-CONECT addresses both limitations by delivering the conversational intervention through a conversational artificial intelligence (AI) voice chatbot rather than a human interviewer, and by testing a hypothesized behavioral mechanism: that the intervention increases participants' social self-efficacy (confidence in their ability to engage socially), which in turn increases real-world social engagement.

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Massachusetts
      • Boston、Massachusetts、美国、02129

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Aged 75+
  • Clinical diagnosis of MCI (any subtype) or, when a clinical diagnosis is unavailable, a Telephone-MoCA (T-MoCA) score of 15-17.
  • Identified as socially isolated, defined as meeting both of the following self-reported criteria: (a) lives alone in one's own residence, and (b) engages in conversations lasting 30 minutes or longer no more than twice per week.
  • GDS-15 (15-item Geriatric Depression Scale) at/below 9 (not severely depressed).
  • Social self-efficacy mean ≤ 8 (on the 0-10 scale) across the 6-item Social Self-Efficacy Scale at screening, indicating low confidence in social interaction.
  • Ability to understand the research consent form.
  • Ability to connect a tablet to the Internet.

Exclusion Criteria:

  • Diagnosed with dementia such as AD, ischemic vascular dementia, normal pressure hydrocephalus, or Parkinson's disease.
  • Schizophrenia, or other major psychiatric disorder defined by DSM-IV criteria.
  • Medications: (a) Frequent use of high doses of analgesics; Use of sedative medications except for those used occasionally for sleep (≤2 per week); (b) Use of unstable dosing of Cholinesterase inhibitors (need to be stable dosing for 2 months); (c) AD disease modifying monoclonal antibody treatment e.g., aducanumab or lecanemab (completed the treatment is allowed)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：AI-CONECT
Participants will receive four 15- to 30-minute conversations per week with the AI agent and a weekly 10- to15-minute survey call with a human interviewer.
行为的：AI-based conversational intervention
AI-based one-on-one semi-structured conversation for cognitive stimulation
无干预：Control
Participants will receive a weekly 10- to 15-minute survey call with a human interviewer.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Social Self-Efficacy
大体时间：From enrollment to the end of intervention at 8 weeks
Participants' self-efficacy on social interactions using an instrument adapted from the Exercise Self-Efficacy Scale (EXSE, by McAuley, 1993). The scale comprises three items of confidence: interacting with others regularly, engaging with others when feeling less connected, and engaging others in conversations. The three items are adapted to social interaction in person and using technology (e.g., video calls), respectively. Each item is rated from 0 (not at all confident) to 10 (completely confident). A mean score is computed across the six items (range 0-10), with higher scores indicating greater social self-efficacy.
From enrollment to the end of intervention at 8 weeks
Time contacting friends or family
大体时间：From enrollment to the end of the intervention at 8 weeks, using weekly data
Change in weekly time contacting friends or family.
From enrollment to the end of the intervention at 8 weeks, using weekly data

次要结果测量

结果测量
措施说明
大体时间
Time out of home
大体时间：From enrollment to the end of treatment at 8 weeks
Self-reported weekly time out of home (a proximate measure of social engagement by the participants), using weekly data.
From enrollment to the end of treatment at 8 weeks
Frequency of contacting friends
大体时间：From enrollment to the end of treatment at 8 weeks
Self-reported frequency of contacting friends, using weekly data.
From enrollment to the end of treatment at 8 weeks

其他结果措施

结果测量
措施说明
大体时间
Exploratory outcome: Social isolation score
大体时间：From baseline to week 8

Changes in Lubben's social isolation score (6-item version) from baseline to Week 8.

The 6-item Lubben Social Network Scale (LSNS-6) is a brief measure of social isolation/social network size and support, particularly in older adults. It includes three questions about family ties and three about friendships, assessing the number of people the individual has contact with, feels close to, and can call on for help.

Each item is scored from 0 to 5, giving a total score of 0-30. Higher scores indicate stronger social networks and less social isolation.
From baseline to week 8
Exploratory outcome: Changes in the 3-item UCLA Loneliness Scale (UCLA-3)
大体时间：From baseline to week 8
The 3-item UCLA Loneliness Scale (UCLA-3) is a brief measure of perceived loneliness and social disconnection. It asks how often a person feels a lack of companionship, left out, and isolated from others. Each item is scored from 1 (hardly ever) to 3 (often). The total score ranges from 3 to 9, with higher scores indicating greater loneliness.
From baseline to week 8

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Massachusetts General Hospital

合作者

Arizona State University

调查人员

  • 首席研究员：Hiroko H Dodge, PhD、Massachusetts General Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2028年5月30日

研究完成 (估计的)

2028年9月30日

研究注册日期

首次提交

2026年2月19日

首先提交符合 QC 标准的

2026年7月13日

首次发布 (实际的)

2026年7月14日

研究记录更新

最后更新发布 (实际的)

2026年8月25日

上次提交的符合 QC 标准的更新

2026年8月22日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026P000461

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified transcriptions and other collected data may be shared with external researchers under a Data Use Agreement (DUA). Shareable data may include outcome scores, adherence rates, chatbot-usage metrics, full conversational transcripts (after removal of any incidentally disclosed identifiable information), and audio recordings of sessions. Because raw audio recordings may be inherently identifiable, they will be shared only under a DUA. These data may also be made available to the NIH/NIA Program Official upon request. Data are stored on HIPAA-compliant servers (e.g., MGB Business Dropbox and MGB Azure) and encrypted drives. The participant linkage key is kept within Mass General Brigham. No individual-level data are deposited in public or controlled-access repositories under the current protocol; future repository sharing would require additional IRB review and approval.

IPD 共享时间框架

De-identified data and related materials are available upon request; the current protocol does not specify a fixed availability start or end date. Availability and retention follow Mass General Brigham and NIH record-retention requirements.

IPD 共享访问标准

Requests are reviewed by the study team. Sharing occurs only under an executed Data Use Agreement (DUA) or equivalent research agreement approved by the Mass General Brigham Contracting Office, is limited to de-identified (except audio recording as described above) or aggregated data for the analyses described in the protocol, and contractually prohibits re-identification and onward sharing. Data are transferred only via Mass General Brigham-approved secure, encrypted methods.

IPD 共享支持信息类型

  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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