AI-CONECT: A Conversational AI for Early Dementia Prevention in Socially-Isolated Older Adults (AI-CONECT)
AI-CONECT: A Conversational AI for Early Dementia Prevention in Socially-Isolated Older Adults Based on the Efficacy-Proven I-CONECT Study
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Catherine Young
- 電話番号：617-724-2428
- メール：cyoung@mgh.harvard.edu
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02129
- Massachusetts General Hospital
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コンタクト：
- Catherine Young
- 電話番号：617-724-2428
- メール：cyoung@mgh.harvard.edu
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コンタクト：
- Junyuan Hong, PhD
- 電話番号：517-668-5790
- メール：mr.junyuan.hong@gmail.com
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参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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AI-based one-on-one semi-structured conversation for cognitive stimulation
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介入なし：Control
Participants will receive a weekly 10- to 15-minute survey call with a human interviewer.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Social Self-Efficacy
時間枠：From enrollment to the end of intervention at 8 weeks
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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.
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From enrollment to the end of intervention at 8 weeks
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Time contacting friends or family
時間枠：From enrollment to the end of the intervention at 8 weeks, using weekly data
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Change in weekly time contacting friends or family.
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From enrollment to the end of the intervention at 8 weeks, using weekly data
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Time out of home
時間枠：From enrollment to the end of treatment at 8 weeks
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Self-reported weekly time out of home (a proximate measure of social engagement by the participants), using weekly data.
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From enrollment to the end of treatment at 8 weeks
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Frequency of contacting friends
時間枠：From enrollment to the end of treatment at 8 weeks
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Self-reported frequency of contacting friends, using weekly data.
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From enrollment to the end of treatment at 8 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Exploratory outcome: Social isolation score
時間枠：From baseline to week 8
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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
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Exploratory outcome: Changes in the 3-item UCLA Loneliness Scale (UCLA-3)
時間枠：From baseline to week 8
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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.
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From baseline to week 8
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協力者と研究者
捜査官
- 主任研究者：Hiroko H Dodge, PhD、Massachusetts General Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2026P000461
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- ANALYTIC_CODE
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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