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

Estudi de l'Impacte de la Soledat no Volguda Incorporant un Robot Social en Centres Residencials

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Wellbeing; Elderly People; Loneliness; Social Interaction; Nursing Home Residents
• Intervention / Treatment: Other: Usual Care; Other: Cognitive; Other: Mobility; Other: Social; Other: Relational

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Domenech Pou, PhD; Phone Number: +34 934464517; Email: sara.domenech@uab.cat
• Study Contact Backup: Name: Nuria Infiesta; Phone Number: +34 649646805; Email: ninfiesta@yasyt.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; This group will do the usual therapies and activities that were doing before the enrolment in the study	Other: Usual Care; Attentions and treatments received by the persons before the enrollment in the study.
Experimental: Robot; 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: Usual Care; Attentions and treatments received by the persons before the enrollment in the study.; Other: Cognitive; Tree 10 minutes individual sessions per week involving memory, attention and executive functions tasks.; Other: Mobility; Two 30 minutes group session per week involving physical activity assisted by a social robot.; Other: Social; One 60 minutes group session per month assisted by a social robot that facilitates talking about costumes and traditions.; Other: Relational; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Well-being	Change in the World Health Organisation- Five Well-Being Index (WHO-5).The WHO-5 is a short, self-administered measure of well-being over the last two weeks. It consists of five positively worded items that are rated on 6-point Likert scale, ranging from 0 (at no the time) to 5 (all of the time). The total score ranges from 0 to 100, with lower scores indicating worse well-being.	weeks 0, 8 and 12
Quality of life, irrespective of the disease	Change in the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L). The EQ-5D-5L can assess patients' quality of life, irrespective of the disease. It covers 5 dimensions of health (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with 5 levels of severity in each dimension (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). The descriptive system defines 3,125 distinct health-states. Responses can be combined in a form of a 5-digit number (the best state "11111" meaning no problems at any of dimension to the worst state "55555" meaning unable/extreme problems at all five dimensions). The second part of the instrument is a 20 cm visual analog scale (EQ VAS) ranging from 0 (worst health you can imagine) to 100 (best health you can imagine)	weeks 0, 8 and 12
Satisfaction with life	Change in the Satisfaction With Life Scale (SWLS). A 5-item scale designed to measure global cognitive judgments of one's life satisfaction (not a measure of either positive or negative affect). Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7 strongly agree to 1 strongly disagree. The five responses are summed to produce a total score for the scale. Total scores can, thus, range from a minimum of 5 to a maximum of 35. Higher scores indicate greater degrees of satisfaction with life.	weeks 0, 8 and 12
Depressive symptoms	Change in 5-item version of Yesavage's Geriatric Depression Scale (GDS-5). This is useful for identify depressive symptoms among elder people. The presence of 2 or more depressive symptoms is indicative of depression. Higher scores indicate greater degrees of depressive symptoms.	weeks 0, 8 and 12
Social Support	Change in the Lubben Social Network Scale (LSNS-6). It is a self-report measure of social engagement including family and friends. The total score is calculated by finding the sum of all items. the score ranges between 0 and 30, with a higher score indicating more social engagement It is a self-report measure of social engagement including family and friends. The total score is calculated by finding the sum of all items. the score ranges between 0 and 30, with a higher score indicating more social engagement	weeks 0, 8 and 12
Communication	Change in the Holden Communication Scale (HCS). This is a scale of 12 items rated from 0 to 4 points completed by a professional based on observation of the person with dementia for a certain period of time. It quantifies, based on the degree of deterioration, those aspects that relate the interrelation of the patient with his immediate environment, and the variables refer to observation, knowledge of reality and communication. A higher score indicates greater impairment.	weeks 0, 8 and 12

Collaborators and Investigators

• Sponsor: Sara Domenech

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 31, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 31, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; nursing homes; loneliness; wellbeing; social robots
• Other Study ID Numbers: FSIE2024Robot; 6773 (Other Identifier: CERec UAB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Informed consent states that data will not be used by other persons.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No