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

22 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

80

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: AI-based conversational intervention
AI-based one-on-one semi-structured conversation for cognitive stimulation
Sem intervenção: Control
Participants will receive a weekly 10- to 15-minute survey call with a human interviewer.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Social Self-Efficacy
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Time out of home
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Exploratory outcome: Social isolation score
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Massachusetts General Hospital

Colaboradores

Arizona State University

Investigadores

  • Investigador principal: Hiroko H Dodge, PhD, Massachusetts General Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

30 de maio de 2028

Conclusão do estudo (Estimado)

30 de setembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

19 de fevereiro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de julho de 2026

Primeira postagem (Real)

14 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2026P000461

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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.

Prazo de Compartilhamento de IPD

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.

Critérios de acesso de compartilhamento IPD

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.

Tipo de informação de suporte de compartilhamento de IPD

  • ANALYTIC_CODE

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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