Mild Cognitive Impairment (MCI), Social Isolation
Conditions
Keywords
Social Isolation, Artificial Intelligence, AI-Chatbot, I-CONECT, Mild Cognitive Impairment (MCI)
Brief summary
This randomized controlled trial examines the mechanisms of conversational AI-based interventions for early dementia prevention in socially isolated older adults.
Detailed description
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.
Interventions
BEHAVIORALAI-based conversational intervention
AI-based one-on-one semi-structured conversation for cognitive stimulation
Sponsors
Massachusetts General Hospital
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Social Self-Efficacy | 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. |
| Time contacting friends or family | From enrollment to the end of the intervention at 8 weeks, using weekly data | Change in weekly time contacting friends or family. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time out of home | 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. |
| Frequency of contacting friends | From enrollment to the end of treatment at 8 weeks | Self-reported frequency of contacting friends, using weekly data. |
Countries
United States
Contacts
CONTACTCatherine Young
PRINCIPAL_INVESTIGATORHiroko H Dodge, PhD
Massachusetts General Hospital
Outcome results
None listed