AI-CONECT: A Conversational AI for Early Dementia Prevention in Socially-Isolated Older Adults (AI-CONECT)
22. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Catherine Young
- Telefonnummer: 617-724-2428
- E-post: cyoung@mgh.harvard.edu
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02129
- Massachusetts General Hospital
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Ta kontakt med:
- Catherine Young
- Telefonnummer: 617-724-2428
- E-post: cyoung@mgh.harvard.edu
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Ta kontakt med:
- Junyuan Hong, PhD
- Telefonnummer: 517-668-5790
- E-post: mr.junyuan.hong@gmail.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Ingen inngripen: Control
Participants will receive a weekly 10- to 15-minute survey call with a human interviewer.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Social Self-Efficacy
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Time out of home
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Exploratory outcome: Social isolation score
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Hiroko H Dodge, PhD, Massachusetts General Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
30. mai 2028
Studiet fullført (Antatt)
30. september 2028
Datoer for studieregistrering
Først innsendt
19. februar 2026
Først innsendt som oppfylte QC-kriteriene
13. juli 2026
Først lagt ut (Faktiske)
14. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026P000461
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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-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.
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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