Aging ProblemsGUARDIANNCT05284292
GUARDIAN: The Social Robot Companion to Support Homecare Nurses
A study testing GUARDIAN platform in people with Aging Problems and Caregiver, run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in 3 countries.
Trial summary
The primary objective of this study is to verify the acceptability of the GUARDIAN system by the elderly, detected through the scale Unified Theory of Acceptance and Use of Technology (UTAUT). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging Problems, Caregiver
- What is being tested?
- GUARDIAN platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 16 Mar 2022to 31 Dec 2022
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- Cognitive integrity (Mini Mental State Examination >=24)
- Have an informal caregiver
- Healthy sight and hearing
Who cannot join
- Mini Mental State Examination < 24
- Lack of informal caregivers
- Sight and hearing not intact
- Lack of informed consent
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
The primary objective of this study is to verify the acceptability of the GUARDIAN system by the elderly, detected through the scale Unified Theory of Acceptance and Use of Technology (UTAUT). The GUARDIAN platform consists of two connected apps: one dedicated to the caregiver and one dedicated to the older people, plus a robot (Misty II). Misty II will live with the elderly, it will have the task of detecting his presence inside the house, reminding him of appointments, assisting him in his daily activities and diminishing the sense of loneliness. The application dedicated to the caregiver receives the data and self reports of the elderly from the robot, in order to constantly offer an updated picture of the condition of the elderly and to keep them informed about their condition and well-being.
Read the detailed description
The primary objective of this study is to verify the acceptability of the GUARDIAN platform by the elderly, detected through the scale Unified Theory of Acceptance and Use of Technology (UTAUT). The aim of this project is to enable the older adult to live as long as possible at home, involving the informal caregiver, using the available technologies. The GUARDIAN platform consists of the Senior App, the Caregiver App and the Misty II robot. The Senior App is an easy-to-use application that will ask the elderly for health status, whether they have carried out their daily activities, if they have taken pre-establishable drugs and if they have eaten properly. The application will generate self-reports that will be transmitted to the app caregiver. The elderly can answer the questions via a tablet on the robot or by voice. The Caregiver App is the application intended for the caregiver, in which you can set up reminders for the elderly about meals or drugs, send communications and ask for reports on his health. This application will be used by both the informal caregiver and the formal caregiver (health care professional). It is the social robot that will complete the platform. Reminders will be sent via the robot and questions will be asked to the patient. The trial will consist of two phases involving, in each of the three participant countries (Italy, Nederlands and Switzerland), 4 seniors with their informal caregivers in the Alpha phase and 10 seniors with their informal caregivers in the following GUARDIAN trial. In both phases the presence of a formal caregiver is expected. In the Alpha phase 4 users and their caregivers will use a first version of the GUARDIAN platform, for three months. The results and feedback from the Alpha phase will give indications to improve and refine the platform.
The GUARDIAN trial involves the enrollment of 10 elderly people in each of the three participant countries (different from those recruited in the Alpha phase) and their respective informal caregivers. The evaluations will be carried out at baseline (T0) and then every month, for three months (T1, T2, T3).
- Conditions
- Aging Problems, Caregiver
- Being tested
- GUARDIAN platform
- Keywords
- Health informatics, Attitude to computers, Technology, Technological Innovations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GUARDIAN platformDevice
The enrolled elderly subjects and their caregivers will use at home the GUARDIAN platform consists of the Senior App, the Caregiver App and the Misty II robot.
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | The Guardian platform consists of the robot Misty II, the Senior App and the Caregiver App will be tested by the elderly subjects together with their caregivers Receives: Device: GUARDIAN platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the acceptability of the GUARDIAN platform
Acceptability will be assessed using a 32-item questionnaire based on the unified theory of acceptance and use of technology (UTAUT) model. It's a standardized instrument for measuring the likelihood of success for new technology introductions and helps to understand the drivers of its acceptance.
The questionnaire has 32 questions distributed in 4 key constructs: 1) performance expectancy, 2) effort expectancy, 3) social influence, and 4) facilitating conditions.
Each question are based on a Likert-type 5-point scale ranging from 1 = strongly disagree to 5 = strongly agree. Increments are integers between 1 to 5.
Measured: change from baseline to 1, 2 and 3 months after intervention commencement
Secondary outcomes (4)
Care load of the informal caregiver
Zarit Burden Interview (Chattat R. et al. 2011)
Measured: change from baseline to 1, 2 and 3 months after intervention commencement
Caregiver's Stress and Anxiety
The General Anxiety Disorder-7 (GAD-7) is used to measure the severity of anxiety. Score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
Measured: change from baseline to 1, 2 and 3 months after intervention commencement
Quality of life of the elderly
The Euro QoL 5D-5L quality of life scale is a survey of perceived quality of life that consists of 5 domains: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression; each domain is evaluated with an inverse Likert scale of 5 points where 1 indicates the absence of a problem and 5 the most extreme problem. It also consists of a subscale that evaluates the level of global health through a visual analog scale of 100 points. A unique health state is defined by combining 1 level from each of the 5 dimensions, this combination can be converted into a single index value by facilitating the calculation of quality-adjusted life years (QALYs).
Measured: change from baseline to 1,2 and 3 months after intervention commencement
Elderly person's perception of their health
SF-12 Health Survey (SF-12) is composed of 12 items that produce two measurements related to two different aspects of health: physical health and mental health
Measured: change from baseline to 1, 2 and 3 months after intervention commencement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start16 Mar 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aging ProblemsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284292
- Sponsor's protocol ID
- INRCA_001_2022
- Acronym
- GUARDIAN
- Status last verified
- Oct 2023
- First submitted
- 8 Mar 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Margaritini A, Benadduci M, Amabili G, Bonfigli AR, Luzi R, Wac K, Nap HH, Maranesi E, Bevilacqua R. The social robot companion to support homecare nurses: The guardian study protocol. Contemp Clin Trials Commun. 2022 Oct 30;30:101024. doi: 10.1016/j.conctc.2022.101024. eCollection 2022 Dec.
PubMed 36340699
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GUARDIAN: The Social Robot Companion to Support Homecare Nurses
- ClinicalTrials.gov ID
- NCT05284292
- Acronym / sponsor ID
- GUARDIAN / INRCA_001_2022
- Conditions
- Aging Problems, Caregiver
- Keywords
- Health informatics, Attitude to computers, Technology, Technological Innovations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 Mar 2022 (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 primary objective of this study is to verify the acceptability of the GUARDIAN system by the elderly, detected through the scale Unified Theory of Acceptance and Use of Technology (UTAUT). The GUARDIAN platform consists of two connected apps: one dedicated to the caregiver and one dedicated to the older people, plus a robot (Misty II). Misty II will live with the elderly, it will have the task of detecting his presence inside the house, reminding him of appointments, assisting him in his daily activities and diminishing the sense of loneliness. The application dedicated to the caregiver receives the data and self reports of the elderly from the robot, in order to constantly offer an updated picture of the condition of the elderly and to keep them informed about their condition and well-being.
Detailed description
The primary objective of this study is to verify the acceptability of the GUARDIAN platform by the elderly, detected through the scale Unified Theory of Acceptance and Use of Technology (UTAUT). The aim of this project is to enable the older adult to live as long as possible at home, involving the informal caregiver, using the available technologies. The GUARDIAN platform consists of the Senior App, the Caregiver App and the Misty II robot. The Senior App is an easy-to-use application that will ask the elderly for health status, whether they have carried out their daily activities, if they have taken pre-establishable drugs and if they have eaten properly. The application will generate self-reports that will be transmitted to the app caregiver. The elderly can answer the questions via a tablet on the robot or by voice. The Caregiver App is the application intended for the caregiver, in which you can set up reminders for the elderly about meals or drugs, send communications and ask for reports on his health. This application will be used by both the informal caregiver and the formal caregiver (health care professional). It is the social robot that will complete the platform. Reminders will be sent via the robot and questions will be asked to the patient. The trial will consist of two phases involving, in each of the three participant countries (Italy, Nederlands and Switzerland), 4 seniors with their informal caregivers in the Alpha phase and 10 seniors with their informal caregivers in the following GUARDIAN trial. In both phases the presence of a formal caregiver is expected. In the Alpha phase 4 users and their caregivers will use a first version of the GUARDIAN platform, for three months. The results and feedback from the Alpha phase will give indications to improve and refine the platform.
The GUARDIAN trial involves the enrollment of 10 elderly people in each of the three participant countries (different from those recruited in the Alpha phase) and their respective informal caregivers. The evaluations will be carried out at baseline (T0) and then every month, for three months (T1, T2, T3).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Device: GUARDIAN platformThe Guardian platform consists of the robot Misty II, the Senior App and the Caregiver App will be tested by the elderly subjects together with their caregivers |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Cognitive integrity (Mini Mental State Examination >=24)
- Have an informal caregiver
- Healthy sight and hearing
Key exclusion criteria (4 listed)
- Mini Mental State Examination < 24
- Lack of informal caregivers
- Sight and hearing not intact
- Lack of informed consent
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 |
|---|---|---|
| GUARDIAN platformThe enrolled elderly subjects and their caregivers will use at home the GUARDIAN platform consists of the Senior App, the Caregiver App and the Misty II robot. | Device | experimental arm |
Primary outcome
Change in the acceptability of the GUARDIAN platform
Time frame: change from baseline to 1, 2 and 3 months after intervention commencement
Acceptability will be assessed using a 32-item questionnaire based on the unified theory of acceptance and use of technology (UTAUT) model. It's a standardized instrument for measuring the likelihood of success for new technology introductions and helps to understand the drivers of its acceptance. The questionnaire has 32 questions distributed in 4 key constructs: 1) performance expectancy, 2) effort expectancy, 3) social influence, and 4) facilitating conditions. Each question are based on a Likert-type 5-point scale ranging from 1 = strongly disagree to 5 = strongly agree. Increments are integers between 1 to 5.
4 secondary outcomes
Care load of the informal caregiver
Time frame: change from baseline to 1, 2 and 3 months after intervention commencement
Caregiver's Stress and Anxiety
Time frame: change from baseline to 1, 2 and 3 months after intervention commencement
Quality of life of the elderly
Time frame: change from baseline to 1,2 and 3 months after intervention commencement
Elderly person's perception of their health
Time frame: change from baseline to 1, 2 and 3 months after intervention commencement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 36340699Margaritini A, Benadduci M, Amabili G, Bonfigli AR, Luzi R, Wac K, Nap HH, Maranesi E, Bevilacqua R. The social robot companion to support homecare nurses: The guardian study protocol. Contemp Clin Trials Commun. 2022 Oct 30;30:101024. doi: 10.1016/j.conctc.2022.101024. eCollection 2022 Dec.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GUARDIAN platform in people with Aging Problems and Caregiver, run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in 3 countries.
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 4 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: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the acceptability of the GUARDIAN platform (time frame: change from baseline to 1, 2 and 3 months after intervention commencement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05284292, which also lists 1 linked publication.
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 23 Oct 2023.