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NCT Number: NCT07102017

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Loneliness Behavior Behavioral Symptoms Depression Depression - Major Depressive Disorder Personal Satisfaction Psychological Well-Being Social Behavior Social Isolation Well-Being, Psychological

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Jiao Tong University

Shanghai, 200240, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Co-Design LOVOT Intervention

Device

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

Device

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.

Primary outcomes

  1. Loneliness

    Time frame: From enrollment to the end of treatment at 24 weeks

    Measure the loneliness of participants at baseline before the intervention (T0), at the end of Week 2 (T1) following the initial interaction period, at the end of Week 8 (T2) upon completion of the core intervention phase, and at Week 12 (T3) and Week 24 (T4) to assess the sustained effects of the intervention.

  2. Depression

    Time frame: From enrollment to the end of treatment at 24 weeks.

    Depressive Symptoms will be assessed using the Chinese version of the 15-item Geriatric Depression Scale (GDS-15) at baseline before the intervention (T0), at the end of Week 2 (T1) following the initial interaction period, at the end of Week 8 (T2) upon completion of the core intervention phase, and at Week 12 (T3) and Week 24 (T4).

Secondary outcomes

  1. Self-Efficacy

    Time frame: From enrollment to the end of treatment at 24 weeks

    General Self-Efficacy will be measured by the Chinese version of the General Self-Efficacy Scale (GSES) at baseline before the intervention (T0), at the end of Week 2 (T1) following the initial interaction period, at the end of Week 8 (T2) upon completion of the core intervention phase, and at Week 12 (T3) and Week 24 (T4).

  2. Quality of life and Wellbeing

    Time frame: From enrollment to the end of treatment at 24 weeks

    Quality of Life will be evaluated using the WHO-5 Well-Being Index at baseline before the intervention (T0), at the end of Week 2 (T1) following the initial interaction period, at the end of Week 8 (T2) upon completion of the core intervention phase, and at Week 12 (T3) and Week 24 (T4).

Other outcomes

  1. Interaction engagement

    Time frame: From enrollment to the end of treatment at 8 weeks

    The degree of engagement experienced during interactions will be captured using a scale that measures the level of absorption and focused engagement with the robot at pre- and post-intervention time points (T1, T2)

  2. Self-disclosure

    Time frame: From enrollment to the end of treatment at 8 weeks.

    Participants' intention of sharing personal information, thoughts, feelings, and experiences when interacting with the robot will be evaluated through a measure of self-disclosure specific to the human-robot interaction context at pre-intervention and post-intervention time points (T1, T2).

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Acronym: RoSELL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2025
Registry last updated
Nov 19, 2025

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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