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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07102017
Acronym
RoSELL
Enrollment
90
Registered
2025-08-03
Start date
2025-05-06
Completion date
2026-04-01
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DEVICECo-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.

DEVICEStandard 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.

Sponsors

Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
LonelinessFrom enrollment to the end of treatment at 24 weeksMeasure 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.
DepressionFrom 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

MeasureTime frameDescription
Self-EfficacyFrom enrollment to the end of treatment at 24 weeksGeneral 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).
Quality of life and WellbeingFrom enrollment to the end of treatment at 24 weeksQuality 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

MeasureTime frameDescription
Interaction engagementFrom enrollment to the end of treatment at 8 weeksThe 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)
Self-disclosureFrom 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).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026