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Active Not RecruitingNCT07102017

A Randomized Controlled Trial of Robotic Support for Enhanced Later Life (RoSELL)

The Impact of Socially Supportive Robotic Intervention on Loneliness, Depression, Self-agency and Well-being in Long-term Care Residents: A Three-Arm Randomized Controlled Trial

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
90 (estimated)
Sponsor
Shanghai Jiao Tong University School of Medicine · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to compare the efficacy of a personalized, co-designed robot interaction against a standardized, fixed robot interaction for reducing loneliness, depression, as well as improving self-agency and quality of life in older adults. This is a three-arm randomized controlled trial. The study will be conducted at a community center in Fuzhou, China, with 100 participants aged 65+ recruited from the facility. The participants will be randomly assigned to one of three conditions: (1) Co-designed robot (CL) group receiving a personalized robot interaction with a structured co-design ceremony; (2) Standard robot (SL) group interacting with an identical robot without personalization features; or (3) An attention-controlled usual care (CU) group. The intervention comprises 16 sessions (two weekly 20-minute sessions over eight weeks). The primary outcomes are loneliness and depressive symptoms. Secondary outcomes include general self-efficacy, quality of life, as well as staff and participants' perceptions of the robot. Mechanism measures (i.e., engagement, self-disclosure) and manipulation checks (e.g., perceived personal role) will be employed to elucidate the underlying theoretical pathways. Data will be collected at baseline (T0), after the initial 2-week co-design period (T1), post-intervention (T2, Week 8), and at 1-month (T3) and 3-month (T4) follow-ups.

Conditions

Interventions

TypeNameDescription
DEVICECo-Design LOVOT InterventionThis arm utilizes the LOVOT robot within a structured protocol designed to foster a unique personal attachment through a co-design ceremony and anthropomorphic framing. Personalization Ritual (Sessions 1-2): A healthcare professional facilitates a multi-phase personalization ceremony. Autonomous Interaction (Sessions 3-16): The personalized LOVOT is placed in the participant's room. The robot consistently uses the participant-chosen voice and eye settings.
DEVICEStandard LOVOT InterventionThis arm uses the identical LOVOT robot for an equivalent duration but deliberately excludes personalization and anthropomorphic framing to isolate the effect of generic robot companionship. Standardized Introduction (Sessions 1-2): A healthcare professional introduces the LOVOT robot with a fixed, generic configuration. Neutral Autonomous Interaction (Sessions 3-16): The standard LOVOT is placed in the participant's room. The robot operates with its default outgoing personality and identical sensors (thermal camera, touch, distance) for safe, autonomous movement and recharging.

Timeline

Start date
2025-05-06
Primary completion
2026-04-01
Completion
2026-04-01
First posted
2025-08-03
Last updated
2025-11-19

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07102017. Inclusion in this directory is not an endorsement.