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Clinical Trials in China / NCT07102017
Active, not recruiting Not applicable

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

NCT07102017 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Jiao Tong University School of Medicine
Phase
Not applicable
Started
2025-05-06
Last updated
2025-11-19

Condition(s) studied

LonelinessWell-Being, PsychologicalDepression - Major Depressive Disorder

Investigational drug(s) / intervention(s)

Co-Design LOVOT InterventionStandard LOVOT Intervention

Co-Design LOVOT Intervention: This 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.

Standard LOVOT Intervention: This 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.

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
Healthy volunteers
Accepted
The inclusion criteria of this program are: (1) being aged 65 or above, (2) living within the elderly community center for at least 1 month, and (3) being capable of interacting with a robot. The participants were not eligible if they were: (1) already engaged in other socially assistive robot programs, (2) diagnosed with severe psychiatric problems, (3) bed-bound, or (4) living in an area with no Internet coverage.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Jiao Tong University Shanghai China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07102017 on ClinicalTrials.gov ↗ ← All trials in China