A Mechanism Randomised Controlled Trial of a Three-Agent LLM-Augmented mHealth Intervention for Late-Life Loneliness in Older Adults

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorThe University of Hong Kong

About this trial

This study examines how a smartphone conversational application affects feelings of loneliness in Cantonese-speaking older adults living in Hong Kong. Seventy-two adults aged 60 or above who report at least moderate loneliness will be randomly assigned to one of two versions of the same application. Both versions look and work the same way, offer the same three conversational companions, and provide the same set of in-app tools. The two versions differ only in how the companions' replies are produced: in one version replies are generated by a large language model, and in the other they are assembled from pre-written templates selected by keyword and conversation state. Participants use the application for four weeks and are then followed for a further four weeks with continued access. The main question is whether any difference between the two versions in emotional loneliness operates through how understood, validated and cared for participants feel during individual conversations. Participants are not told which version they are using, and the researcher who carries out the assessments is also unaware of the assignment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 60 years or above

Self-identified Cantonese as primary language of communication

Community-dwelling in Hong Kong (not in residential care)

De Jong Gierveld Emotional and Social Loneliness Scale total score of 2 or above at screening, indicating at least moderate loneliness

Disqualifiers

Acute suicidality, defined as a PHQ-9 item 9 score above 1 with reported active intent

Currently receiving formal psychiatric treatment

Severe hearing or visual impairment precluding application use even with accommodation

Self-reported diagnosis of dementia or significant cognitive impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hybrid conversational companion application

    Behavioral

    Mobile application providing three named Cantonese-language conversational companions plus four in-app tools (Action Loop, Thought Exercise, Education, Progress). Companion replies are generated turn-by-turn by a large language model (DeepSeek-V3, accessed via Firebase Cloud Functions), conditioned on the companion's system prompt, retrieved conversation history, and current user input. This arm can therefore produce five conversational behaviours the comparator cannot: anchoring on specific content the participant has just said, memory carried across separate sessions, explicit admission of unfamiliarity, routing of single messages containing mixed emotional and informational content, and generative summarisation. Occurrences are tagged in system logs and analysed as a cumulative within-arm exposure variable. Conversational text is transmitted to the model provider for response generation; participants are advised at consent not to include identifying information. Recommended use is a

  • Rule-based conversational companion application

    Behavioral

    Mobile application identical to the experimental arm in interface, navigation, companion names and personae, tool layer (Action Loop, Thought Exercise, Education, Progress), notification schedule, and all in-app assessment prompts. The sole difference is the response-generation backend: companion replies are assembled from pre-written templates selected by keyword matching and conversational state, with no language model involved. The system retains no memory across sessions, cannot anchor on unanticipated content, cannot admit unfamiliarity outside scripted cases, and cannot generate novel summaries. Conversational content is not transmitted to any external service. This is an attention- and interface-matched active comparator rather than a waitlist or usual-care control: participants receive equivalent contact time, interface richness, tool access, and prompting schedule. Recommended use, expected daily duration, and logging are identical to the experimental arm.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Hybrid arm (LLM-driven)Experimental treatment 1 intervention
Group B: Rule-based arm (template-driven)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Session-level perceived responsiveness (primary mediator)

Brief perceived-responsiveness measure administered in-app immediately after each companion conversation. Single-item sliders scored 1-7 covering Understanding, Validation, Caring and Insensitivity. Higher scores indicate greater perceived responsiveness. This is the within-person mediator in the pre-specified primary mediation model, not an efficacy endpoint.

Time frame
After each conversation session, Weeks 1 through 4
2

Change in emotional loneliness (De Jong Gierveld emotional subscale)

De Jong Gierveld Emotional and Social Loneliness Scale, 3-item emotional subscale. Score range 0-3; higher scores indicate greater emotional loneliness. Change from baseline to Week 4. This is the outcome variable in the pre-specified primary mediation model. The trial is powered for the indirect effect via session-level perceived responsiveness and is not powered for confirmatory testing of the between-arm difference, which is reported as an effect estimate with a 95% confidence interval.

Time frame
Baseline (Week 0) and Week 4

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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