AI-CONECT: A Conversational AI for Early Dementia Prevention in Socially-Isolated Older Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorMassachusetts General Hospital
About this trial
This randomized controlled trial examines the mechanisms of conversational AI-based interventions for early dementia prevention in socially isolated older adults.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
AI-based conversational intervention
BehavioralAI-based one-on-one semi-structured conversation for cognitive stimulation
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: AI-CONECTExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Social Self-Efficacy
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 frame
From enrollment to the end of intervention at 8 weeks2
Time contacting friends or family
Change in weekly time contacting friends or family.
Time frame
From enrollment to the end of the intervention at 8 weeks, using weekly dataSecondary outcomes
1
Time out of home
Self-reported weekly time out of home (a proximate measure of social engagement by the participants), using weekly data.
Time frame
From enrollment to the end of treatment at 8 weeks2
Frequency of contacting friends
Self-reported frequency of contacting friends, using weekly data.
Time frame
From enrollment to the end of treatment at 8 weeksOther outcomes
1
Exploratory outcome: Social isolation score
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.
Time frame
From baseline to week 82
Exploratory outcome: Changes in the 3-item UCLA Loneliness Scale (UCLA-3)
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.
Time frame
From baseline to week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Arizona State University
Collaborator
Source ClinicalTrials.gov
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