Elderly PeopleWITHPEPPERNCT06344676
Study of the Impact of a Social Robot on Unwanted Loneliness in Elderly People Living in Nursing Homes
A study testing Cognitive, Mobility and Social in people with Elderly People and Nursing Home Residents, run by Sara Domenech.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly People, Nursing Home Residents, Loneliness
- What is being tested?
- Cognitive, Mobility and Social
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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
- Being tested
- Cognitive, Mobility, Social, Relational, Usual Care
- Keywords
- social robots, loneliness, nursing homes, quality of life, wellbeing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CognitiveOther
Tree 10 minutes individual sessions per week involving memory, attention and executive functions tasks.
MobilityOther
Two 30 minutes group session per week involving physical activity assisted by a social robot.
SocialOther
One 60 minutes group session per month assisted by a social robot that facilitates talking about costumes and traditions.
RelationalOther
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.
Usual CareOther
Attentions and treatments received by the persons before the enrollment in the study.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | This group will do the usual therapies and activities that were doing before the enrolment in the study Receives: 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 Receives: Other: Cognitive; Other: Mobility; Other: Social; Other: Relational; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: weeks 0, 8 and 12
Secondary outcomes (6)
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: weeks 0, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sara Domenech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Domenech, Fundacio Salut i Envelliment UAB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344676
- Sponsor's protocol ID
- FSIE2024Robot
- Other IDs
- 6773
- Acronym
- WITHPEPPER
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Informed consent states that data will not be used by other persons.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudi de l'Impacte de la Soledat no Volguda Incorporant un Robot Social en Centres Residencials
- ClinicalTrials.gov ID
- NCT06344676
- Acronym / sponsor ID
- WITHPEPPER / FSIE2024Robot
- Conditions
- Elderly People, Nursing Home Residents, Loneliness, Quality of Life, Wellbeing, Social Interaction
- Keywords
- social robots, loneliness, nursing homes, quality of life, wellbeing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Sara DomenechUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareThis group will do the usual therapies and activities that were doing before the enrolment in the study |
| Robot | Experimental | Other: Cognitive, Other: Mobility, Other: Social, Other: Relational, Other: Usual CareThis 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CognitiveTree 10 minutes individual sessions per week involving memory, attention and executive functions tasks. | Other | Robot |
| MobilityTwo 30 minutes group session per week involving physical activity assisted by a social robot. | Other | Robot |
| SocialOne 60 minutes group session per month assisted by a social robot that facilitates talking about costumes and traditions. | Other | Robot |
| RelationalUnrestricted 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. | Other | Robot |
| Usual CareAttentions and treatments received by the persons before the enrollment in the study. | Other | Robot, Usual Care |
Primary outcome
Loneliness
Time frame: weeks 0, 8 and 12
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.
6 secondary outcomes
Well-being
Time frame: weeks 0, 8 and 12
Quality of life, irrespective of the disease
Time frame: weeks 0, 8 and 12
Satisfaction with life
Time frame: weeks 0, 8 and 12
Depressive symptoms
Time frame: weeks 0, 8 and 12
Social Support
Time frame: weeks 0, 8 and 12
Communication
Time frame: weeks 0, 8 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No. Informed consent states that data will not be used by other persons.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive, Mobility and Social in people with Elderly People and Nursing Home Residents, run by Sara Domenech.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Domenech Pou, PhD (+34 934464517, sara.domenech@uab.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness (time frame: weeks 0, 8 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.