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

22 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

80

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02129

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: AI-based conversational intervention
AI-based one-on-one semi-structured conversation for cognitive stimulation
Aucune intervention: Control
Participants will receive a weekly 10- to 15-minute survey call with a human interviewer.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Social Self-Efficacy
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Time out of home
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Exploratory outcome: Social isolation score
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Massachusetts General Hospital

Collaborateurs

Arizona State University

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

30 mai 2028

Achèvement de l'étude (Estimé)

30 septembre 2028

Dates d'inscription aux études

Première soumission

19 février 2026

Première soumission répondant aux critères de contrôle qualité

13 juillet 2026

Première publication (Réel)

14 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026P000461

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage 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.

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • ANALYTIC_CODE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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