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

Shanghai Jiao Tong University School of Medicine

Status: Active, not recruiting

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

Treatments: Device: Standard LOVOT Intervention; Device: Co-Design LOVOT Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07102017

school (Other Identifier)

L20250617

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Co-designed robot group

Experimental group

Description:

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."

Treatment:

Device: Co-Design LOVOT Intervention

Standard Robot Group

Experimental group

Description:

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

Treatment:

Device: Standard LOVOT Intervention

Control

No Intervention group

Description:

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.