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

NCT07102017 | Active Not Recruiting DMC

• 2 other identifiers: L20250617school
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Loneliness; Well-Being, Psychological; Depression - Major Depressive Disorder

Keywords

Social isolation; socially assistive robots; loneliness; depression; self-agency; well-being

Outcome Measures

Primary Outcomes (2)

• Loneliness

  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.

  From enrollment to the end of treatment at 24 weeks

• Depression

  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).

  From enrollment to the end of treatment at 24 weeks.

Secondary Outcomes (2)

• Self-Efficacy

  From enrollment to the end of treatment at 24 weeks

• Quality of life and Wellbeing

  From enrollment to the end of treatment at 24 weeks

Other Outcomes (2)

• Interaction engagement

  From enrollment to the end of treatment at 8 weeks

• Self-disclosure

  From enrollment to the end of treatment at 8 weeks.

Study Arms (3)

Co-designed robot group

EXPERIMENTAL

This intervention arm involves a proactive companion robot delivered over 16 sessions, with a core emphasis on structured personalization to foster attachment. Sessions 1-2 (Personalization Ritual): A healthcare professional facilitates a structured, four-phase co-design ceremony. Sessions 3-16 (Autonomous Interaction): The co-designed robot is placed in the participant's room for autonomous interaction. It uses the personalized settings and exhibits default affectionate behaviors (e.g., approaching, responding to touch). To reinforce the bond, the healthcare professional uses scripted phrases attributing agency and memory to the robot (e.g., "\[Robot's Name\] remembers you"). Participants are encouraged to add one new "memory" per session for the robot to "store."

Device: Co-Design LOVOT Intervention

Standard Robot Group

EXPERIMENTAL

This arm involves the same robot for an equivalent duration and number of sessions as the co-design intervention arm, but without the personalization ritual or anthropomorphic framing. Sessions 1-2 (Standardized Introduction): A healthcare professional introduces the same robot, demonstrating its three core, pre-programmed functionalities. The robot has a generic, fixed configuration with identical, pre-set eye color and voice pitch for all participants in this arm. Sessions 3-16 (Neutral, Autonomous Interaction): The standard robot is placed in the participant's room for autonomous interaction. The key differentiator is the deliberately neutral and non-anthropomorphic framing by the healthcare professional

Device: Standard LOVOT Intervention

Control

NO INTERVENTION

All groups will receive the usual community center services. The study district offers standard community-based programming, including group exercises, social events, and recreational activities, all of which are accessible to all residents. Participation is voluntary. To control for attention bias, healthcare professionals will conduct weekly 20-minute individual visits with participants in this group, totaling 16 sessions over the 4-week intervention period.

Interventions

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.

Co-designed robot group

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.

Standard Robot Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Jiao Tong University

Shanghai, 200240, China

Location

MeSH Terms

Conditions

Psychological Well-Being; Social Isolation; Depression

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Social Behavior; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 3, 2025
• Study Start: May 6, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)