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

13. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Aged 75+
  • Clinical diagnosis of MCI, or MMSE ≥ 24 or MoCA ≥ 18 (i.e., early MCI)
  • Identified as socially isolated by at least one of the two criteria: (1)score ≤ 12 on the 6-item Lubben Social Network Scale (LSNS-6); (2) engages in conversations lasting 30 minutes or longer, no more than twice per week, per subject self-report
  • 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: Frequent use of high doses of analgesics; Use of sedative medications except for those used occasionally for sleep (≤2 per week); Use of unstable dosing of Cholinesterase inhibitors (need to be stable dosing for 2 months).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AI-CONECT
Participants will receive four 15-minute conversations per week with the AI agent and a weekly 15-minute survey call with a human interviewer.
Adfærdsmæssigt: AI-based conversational intervention
AI-based one-on-one semi-structured conversation for cognitive stimulation
Ingen indgriben: Control
Participants will receive a weekly 15-minute survey call with a human interviewer.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Social Self-Efficacy
Tidsramme: 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
Tidsramme: From enrollment to the end of intervention at 8 weeks
Change in weekly time contacting friends or family.
From enrollment to the end of intervention at 8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time out of home
Tidsramme: 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).
From enrollment to the end of treatment at 8 weeks
Frequency of contacting friends
Tidsramme: From enrollment to the end of treatment at 8 weeks
Self-reported weekly frequency of contacting friends.
From enrollment to the end of treatment at 8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Massachusetts General Hospital

Efterforskere

  • Ledende efterforsker: Hiroko H Dodge, PhD, Massachusetts General Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. juli 2026

Primær færdiggørelse (Anslået)

28. februar 2028

Studieafslutning (Anslået)

31. marts 2028

Datoer for studieregistrering

Først indsendt

19. februar 2026

Først indsendt, der opfyldte QC-kriterier

13. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026P000461

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified data will be shared with external researchers under a Data Use Agreement (DUA). The de-identified data may include datasets (outcome scores, adherence rates, chatbot-usage metrics), full conversational transcripts, and audio and video recordings of sessions; all are de-identified (direct identifiers removed) before sharing. De-identified data, analytic code, and summary reports are also available to the NIH/NIA Program Official on request. Data are stored on HIPAA-compliant servers (e.g., MGB Business Dropbox, MGB Azure) and encrypted drives. No identifiable data or Limited Data Sets are shared; 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-delingstidsramme

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-delingsadgangskriterier

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 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-deling Understøttende informationstype

  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Mild kognitiv svækkelse (MCI)

Kliniske forsøg med AI-based conversational intervention

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