Study of the Impact of a Social Robot on Unwanted Loneliness in Elderly People Living in Nursing Homes

NCT06344676 | Not Yet Recruiting

• 2 other identifiers: FSIE2024Robot6773
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to assess the usefulness of social robots reducing unwanted loneliness in persons over 65 living in nursing homes. The main questions it aims to answer are:

• Can social robots reduce unwanted loneliness?
• Can social robots improve quality of live and well-being? The selected centers are organized in several classes of living units. Living units are independent physical spaces with their own common facilities for the persons living in (usually around 15). Living units of the same class gather persons with similar characteristics. To compare the added value of the robots half of the living units will be allocated to a control group, and the other half to the intervention group. The persons in living units allocated to the control group will receive the same attentions and care which were receiving before the enrollment in the study, whereas the persons allocated to the intervention group will add a social robot to their usual therapies and activities. Namely participants will do three weekly individual cognitive stimulation sessions of 10 minutes each one, two weekly group mobility sessions of 30 minutes, one monthly conversational group about customs and traditions of 60 minutes, one 10 minutes videoconference per month with their relatives. Furthermore, participants will be able to interact freely with the robot to obtain information about the center (for instance, what is for dinner) and its activities. The intervention will last 8 weeks. To assess the effectivity, the investigators will assess both groups, before the intervention, at the end of the intervention and 4 weeks after finishing the intervention.

Conditions

Elderly People; Nursing Home Residents; Loneliness; Quality of Life; Wellbeing; Social Interaction

Keywords

social robots; loneliness; nursing homes; quality of life; wellbeing

Outcome Measures

Primary Outcomes (1)

• Loneliness

  Change in the UCLA Loneliness Scale (Version 3). The UCLA Loneliness Scale is a 20-item scale (Russell, 1996) that includes statements (e.g., How often do you feel alone?) rated on a four-point Likert scale ranging from 1 (never) to 4 (always). The total score ranges from 20 to 80. Higher scores indicate greater degrees of loneliness.

  weeks 0, 8 and 12

Secondary Outcomes (6)

• Well-being

  weeks 0, 8 and 12

• Quality of life, irrespective of the disease

  weeks 0, 8 and 12

• Satisfaction with life

  weeks 0, 8 and 12

• Depressive symptoms

  weeks 0, 8 and 12

• Social Support

  weeks 0, 8 and 12

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

This group will do the usual therapies and activities that were doing before the enrolment in the study

Other: Usual Care

Robot

EXPERIMENTAL

This group will do the usual therapies and activities that were doing before the enrolment in the study plus: * 3 weekly individual cognitive stimulation sessions of 10 minutes. * 2 weekly group mobility sessions of 30 minutes. * 1 monthly group social session of 60 minutes

Other: Cognitive; Other: Mobility; Other: Social; Other: Relational; Other: Usual Care

Interventions

Cognitive OTHER

Tree 10 minutes individual sessions per week involving memory, attention and executive functions tasks.

Robot

Mobility OTHER

Two 30 minutes group session per week involving physical activity assisted by a social robot.

Robot

Social OTHER

One 60 minutes group session per month assisted by a social robot that facilitates talking about costumes and traditions.

Robot

Relational OTHER

Unrestricted individual interaction of the user with the Pepper robot to obtain information of interest for the user (menu, time, date, place and calendar of activities of the residential. center) and 1 individual monthly videoconference with the family of 10 minutes of duration.

Robot

Usual Care OTHER

Attentions and treatments received by the persons before the enrollment in the study.

Robot; Usual Care

Eligibility Criteria

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

You may qualify if:

• To be 65 years old or older.
• To live indefinitely for more than 6 months in the participating nursing home (to avoid the effect of the adaptation period).
• Provide the informed consent.

You may not qualify if:

• Impossibility to understand and/or answer the loneliness questionnaire for themselves.
• To have physical, cognitive or other conditions preventing the use of the robot platform.

Sponsors & Collaborators

• Sara Domenech: lead

MeSH Terms

Interventions

Range of Motion, Articular; Relational Autonomy

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Personal Autonomy; Principle-Based Ethics; Ethics; Health Care Quality, Access, and Evaluation

Central Study Contacts

Sara Domenech Pou, PhD

CONTACT

+34 934464517; sara.domenech@uab.cat

Nuria Infiesta

CONTACT

+34 649646805; ninfiesta@yasyt.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 3, 2024
• Study Start: April 1, 2024
• Primary Completion: July 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share