Clinical trial NCT06344676: Study of the Impact of a Social Robot on Unwanted Loneliness in Elderly People Living in Nursing Homes
Official title: Estudi de l'Impacte de la Soledat no Volguda Incorporant un Robot Social en Centres Residencials
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Elderly People
Nursing Home Residents
Loneliness
Quality of Life
Wellbeing
Social Interaction
Keywords: social robots
loneliness
nursing homes
quality of life
wellbeing
Lead sponsor: Fundacio Salut i Envelliment UAB
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 162
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Loneliness
timeFrame: weeks 0, 8 and 12
Secondary outcomes:
measure: Well-being
timeFrame: weeks 0, 8 and 12
measure: Quality of life, irrespective of the disease
timeFrame: weeks 0, 8 and 12
measure: Satisfaction with life
timeFrame: weeks 0, 8 and 12
measure: Depressive symptoms
timeFrame: weeks 0, 8 and 12
measure: Social Support
timeFrame: weeks 0, 8 and 12
measure: Communication
timeFrame: weeks 0, 8 and 12
Other outcomes:
Locations:
Study officials:
References: