Massachusetts General Hospital
Boston, Massachusetts, 02129, United States
Location contact
Catherine Young
CONTACT
Junyuan Hong, PhD
CONTACT
NCT Number: NCT07701668
This randomized controlled trial examines the mechanisms of conversational AI-based interventions for early dementia prevention in socially isolated older adults.
Trial opening soon.
Get Notified75 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02129, United States
Catherine Young
CONTACT
Junyuan Hong, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AI-based one-on-one semi-structured conversation for cognitive stimulation
Time frame: 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 frame: From enrollment to the end of the intervention at 8 weeks, using weekly data
Change in weekly time contacting friends or family.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 8 weeks
Self-reported frequency of contacting friends, using weekly data.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Massachusetts General Hospital
Other
AI-CONECT: A Conversational AI for Early Dementia Prevention in Socially-Isolated Older Adults Based on the Efficacy-Proven I-CONECT Study
Acronym: AI-CONECT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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