Mild Cognitive ImpairmentengAGENCT06302686
engAGE: Managing cognitivE decliNe throuGh Theatre Therapy, Artificial Intelligence and Social Robots drivEn Interventions
A study testing engAGE system and Group practicing with only the support of a booklet in people with Mild Cognitive Impairment and Older Adults, run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in 3 countries.
Trial summary
The objectives of the engAGE project are to counteract and slow down cognitive decline progression, to enhance the intrinsic capacity of the users, and to support the wellbeing of older persons with mild cognitive impairment (MCI) by providing an ecosystem of services based on an innovative system that integrates… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Older Adults
- What is being tested?
- engAGE system and Group practicing with only the support of a booklet
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 9 Oct 2023to 24 Jun 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
- No healthy volunteers
- Older adult
Who may be able to join
- mild cognitive impairment (MCI);
- Montreal Cognitive Assessment (MoCA) score 21 - 25;
- Memory Assessment Clinics - Questionnaire (MAC-Q) ≥ 25;
- Reisberg scale 2 - 4;
- Clinical Frailty Scale score 1 - 3;
- 4-items GDS score ≤ 1;
- have an informal caregiver to support in carrying out the main daily activities.
Who cannot join
- lack of informal caregivers;
- significant visual or hearing impairment.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Italy1 site, 1 recruiting
- Recruiting
IRCCS INRCA Hospital
Ancona, 60127
Elvira Maranesi
Roberta Bevilacqua
Norway1 site, 1 recruiting
- Recruiting
Karde A/S
Oslo
Terje Grimstad
Terje Grimstad
Switzerland1 site, 1 recruiting
- Recruiting
HUG
Geneva
Christian Lovis
Christian Lovis
About this study
The objectives of the engAGE project are to counteract and slow down cognitive decline progression, to enhance the intrinsic capacity of the users, and to support the wellbeing of older persons with mild cognitive impairment (MCI) by providing an ecosystem of services based on an innovative system that integrates social robots.
Read the detailed description
The study is focused on older people with mild cognitive impairment, aiming to improve their quality of life and well-being, allowing them to preserve their identity, to reduce stress, memory loss, or communication challenges by the use of the technological engAGE system that includes the social robot Pepper. The social robot can be a great tool in engaging older adults in this kind of activities. It is always available and able to provide verbal clues or suggestions according to older adult's wishes, needs and memories. Moreover, the social robots may coach the older adults to perform daily activities with greater independence (i.e. coaching stepwise prompting to complete activities in-home) and support to caregivers as well.
Since caring for people with mild cognitive impairment puts a significant burden on informal caregivers, having the support of a technological platform can reduce anxiety, worries, and stress. The caregivers can personalize the content of interventions to the wishes and preferences of the older adults. Together with the older adults, they can be involved with the robot in joyful and fun activities like drama playing, storytelling, etc.
The formal caregivers who need to keep track of older adult progress which is a difficult and time-consuming process due to the lack of objective monitoring of cognitive decline and wellbeing may get valuable support from the cognitive assessment procedure implemented by the machine learning algorithm. Also, the social robot and tablet may facilitate the follow-up of older adults through reminders and cognitive interventions.
- Conditions
- Mild Cognitive Impairment, Older Adults
- Being tested
- engAGE system, Group practicing with only the support of a booklet
- Keywords
- ageing, older adults, mild cognitive impairment, caregiver, technological platform
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
engAGE systemDevice
The experimental group use the engAGE system at both healthcare organization and home. At the healthcare organization, the subject interacts with Pepper robot. The interaction is supervised by the formal caregivers and includes the following activities: dialoguing with the robot, storytelling, drama play, cognitive and physical games. This interaction is planned to last about 1 hour twice a week for 6 months. At home, the older user interacts with the tablet supervised by the informal caregiver. The user plays cognitive and physical games installed on MEMAS app. This activity is performed for 0.5 hour, every day for 6 months. Throughout the whole period of experimentation, the older user wears the smartwatch that measures his/her physiological parameters and the steps. Any activity performed by the seniors is assigned by formal caregiver and can be personalized taking into account the user's abilities, lifestyle, and social interactions.
Group practicing with only the support of a bookletOther
To the control group will be given a booklet containing information and activities on well-being to do at home.
| Study group | Role | What they receive |
|---|---|---|
| engAGE group | Experimental | The experimental group will use the technological engAGE system for 6 months. Receives: Device: engAGE system |
| control group | Other | To the control group will be given a booklet containing information and activities on well-being to do at home. Receives: Other: Group practicing with only the support of a booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived stability of cognitive status by the older adults
The Memory Assessment Clinics - Questionnaire (MAC-Q) is a 6-item scale that uses a 5-item Likert scale from "much better now"=1 to "much worse now"=5, and the last question scores double. The questionnaire asks the person to compare his or her memory with a previous period to measure age-related memory decline. Five items address specific situations frequently reported as problematic by those who experience memory loss with age. One item is a global item assessing general memory decline. A cutoff of 25 points or more indicates that the individual has a memory disorder.
Measured: baseline and 6 months later
Secondary outcomes (9)
Change in cognitive impairment in older adults
The Montreal Cognitive Assessment (MoCA) is a screening assessment for detecting cognitive impairment. The MoCA assesses several cognitive domains: the short-term memory recall task (5 points), visuospatial abilities (4 points), alternation task (1 point), verbal abstraction task (1 point), attention, concentration, and working memory (6 points), language (6 points), abstract reasoning (2 points), and orientation to time and place (6 points).Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal.
Measured: baseline and 6 months later
Change in depression in older adults
The 4-items Geriatric Depression Scale (GDS) is a 4-items scale whose answers are yes or no. If all the items are answered negatively then the depression is excluded; if only one item is answered positively then the situation is uncertain; if at least 2 items are answered positively, the patient is depressed.
Measured: baseline and 6 months later
Change in frailty status in older adults
The Clinical Frailty Scale (CFS) is a descriptive scale divides the older participants into 9 classes based on the information provided by them and their relatives: between 1 and 3 the patient is non-frail, pre-frail if 4, he is frail from 5 to 9.
Measured: baseline and 6 months later
Change in mental well being in older adults
The Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS). is used to enable the measuring of mental wellbeing in the general population. The 12-item scale WEMWBS has 5 response categories, summed to provide a single score. Scores range from 7 to 35 and higher scores indicate higher positive mental wellbeing.
Measured: baseline and 6 months later
Change in quality of life in older adults
The EuroQoL-5D-5L scale consists of five dimensions: mobility, independence, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, mild problems, moderate problems, severe problems and extreme problems. The numbers from the five dimensions can be combined into a 5-digit number that describes the health status of the participant.
Measured: baseline and 6 months later
Change in acceptability of the engAGE system in older adults
Acceptability will be assessed by the Unified Theory of Acceptance and Use of Technology test (UTAUT). 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 52 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: baseline and 6 months later
Change in quality of life in informal caregivers
The EuroQoL-5D-5L scale consists of five dimensions: mobility, independence, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, mild problems, moderate problems, severe problems and extreme problems. The numbers from the five dimensions can be combined into a 5-digit number that describes the health status of the participant.
Measured: baseline and 6 months later
Change in mental well being in informal caregivers
The Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) is used to enable the measuring of mental wellbeing in the general population. The 12-item scale WEMWBS has 5 response categories, summed to provide a single score. Scores range from 7 to 35 and higher scores indicate higher positive mental wellbeing.
Measured: baseline and 6 months later
Change in caregiver burden
The Zarit Burden Interview (ZBI) is a caregiver self-report measure, containing 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always).
Measured: baseline and 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start9 Oct 2023
- Primary completion24 Jun 2024 (estimated)
- Study completion24 Jun 2024 (estimated)
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 Mild Cognitive ImpairmentStudies 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
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302686
- Sponsor's protocol ID
- INRCA_004_2023
- Acronym
- engAGE
- Status last verified
- Apr 2023
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amabili G, Maranesi E, Margaritini A, Bonfigli AR, Felici E, Barbarossa F, Benadduci M, Gosetto L, Guebey J, Grimstad T, Hellman R, Marin AI, Boye LT, Anghel IM, Cioara T, Bevilacqua R. Managing Cognitive Decline Through a Social Robot-Based Intervention: Protocol for the engAGE Proof of Concept and Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 2;14:e67601. doi: 10.2196/67601.
PubMed 40896828
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- engAGE: Managing cognitivE decliNe throuGh Theatre Therapy, Artificial Intelligence and Social Robots drivEn Interventions
- ClinicalTrials.gov ID
- NCT06302686
- Acronym / sponsor ID
- engAGE / INRCA_004_2023
- Conditions
- Mild Cognitive Impairment, Older Adults
- Keywords
- ageing, older adults, mild cognitive impairment, caregiver, technological platform
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 24 Jun 2024 (estimated)
- Study completion
- 24 Jun 2024 (estimated)
- First posted
- 12 Mar 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 objectives of the engAGE project are to counteract and slow down cognitive decline progression, to enhance the intrinsic capacity of the users, and to support the wellbeing of older persons with mild cognitive impairment (MCI) by providing an ecosystem of services based on an innovative system that integrates social robots.
Detailed description
The study is focused on older people with mild cognitive impairment, aiming to improve their quality of life and well-being, allowing them to preserve their identity, to reduce stress, memory loss, or communication challenges by the use of the technological engAGE system that includes the social robot Pepper. The social robot can be a great tool in engaging older adults in this kind of activities. It is always available and able to provide verbal clues or suggestions according to older adult's wishes, needs and memories. Moreover, the social robots may coach the older adults to perform daily activities with greater independence (i.e. coaching stepwise prompting to complete activities in-home) and support to caregivers as well.
Since caring for people with mild cognitive impairment puts a significant burden on informal caregivers, having the support of a technological platform can reduce anxiety, worries, and stress. The caregivers can personalize the content of interventions to the wishes and preferences of the older adults. Together with the older adults, they can be involved with the robot in joyful and fun activities like drama playing, storytelling, etc.
The formal caregivers who need to keep track of older adult progress which is a difficult and time-consuming process due to the lack of objective monitoring of cognitive decline and wellbeing may get valuable support from the cognitive assessment procedure implemented by the machine learning algorithm. Also, the social robot and tablet may facilitate the follow-up of older adults through reminders and cognitive interventions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| engAGE group | Experimental | Device: engAGE systemThe experimental group will use the technological engAGE system for 6 months. |
| control group | Other | Other: Group practicing with only the support of a bookletTo the control group will be given a booklet containing information and activities on well-being to do at home. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- mild cognitive impairment (MCI);
- Montreal Cognitive Assessment (MoCA) score 21 - 25;
- Memory Assessment Clinics - Questionnaire (MAC-Q) ≥ 25;
- Reisberg scale 2 - 4;
- Clinical Frailty Scale score 1 - 3;
Key exclusion criteria (2 listed)
- lack of informal caregivers;
- significant visual or hearing impairment.
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 |
|---|---|---|
| engAGE systemThe experimental group use the engAGE system at both healthcare organization and home. At the healthcare organization, the subject interacts with Pepper robot. The interaction is supervised by the formal caregivers and includes the following activities: dialoguing with the robot, storytelling, drama play, cognitive and physical games. This interaction is planned to last about 1 hour twice a week for 6 months. At home, the older user interacts with the tablet supervised by the informal caregiver. The user plays cognitive and physical games installed on MEMAS app. This activity is performed for 0.5 hour, every day for 6 months. Throughout the whole period of experimentation, the older user wears the smartwatch that measures his/her physiological parameters and the steps. Any activity performed by the seniors is assigned by formal caregiver and can be personalized taking into account the user's abilities, lifestyle, and social interactions. | Device | engAGE group |
| Group practicing with only the support of a bookletTo the control group will be given a booklet containing information and activities on well-being to do at home. | Other | control group |
Primary outcome
Change in perceived stability of cognitive status by the older adults
Time frame: baseline and 6 months later
The Memory Assessment Clinics - Questionnaire (MAC-Q) is a 6-item scale that uses a 5-item Likert scale from "much better now"=1 to "much worse now"=5, and the last question scores double. The questionnaire asks the person to compare his or her memory with a previous period to measure age-related memory decline. Five items address specific situations frequently reported as problematic by those who experience memory loss with age. One item is a global item assessing general memory decline. A cutoff of 25 points or more indicates that the individual has a memory disorder.
9 secondary outcomes
Change in cognitive impairment in older adults
Time frame: baseline and 6 months later
Change in depression in older adults
Time frame: baseline and 6 months later
Change in frailty status in older adults
Time frame: baseline and 6 months later
Change in mental well being in older adults
Time frame: baseline and 6 months later
Change in quality of life in older adults
Time frame: baseline and 6 months later
Change in acceptability of the engAGE system in older adults
Time frame: baseline and 6 months later
Change in quality of life in informal caregivers
Time frame: baseline and 6 months later
Change in mental well being in informal caregivers
Time frame: baseline and 6 months later
Change in caregiver burden
Time frame: baseline and 6 months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 40896828Amabili G, Maranesi E, Margaritini A, Bonfigli AR, Felici E, Barbarossa F, Benadduci M, Gosetto L, Guebey J, Grimstad T, Hellman R, Marin AI, Boye LT, Anghel IM, Cioara T, Bevilacqua R. Managing Cognitive Decline Through a Social Robot-Based Intervention: Protocol for the engAGE Proof of Concept and Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 2;14:e67601. doi: 10.2196/67601.
Related trials for Mild Cognitive Impairment
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Parkinson Disease, Mild Cognitive Impairment
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
Recruiting
Combating Alzheimer's Through Sleep and Exercise
Dementia, Mild Cognitive Impairment (MCI)
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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing engAGE system and Group practicing with only the support of a booklet in people with Mild Cognitive Impairment and Older Adults, 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 7 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 12 Mar 2024. 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, Norway, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Rita Bonfigli (0718003719, a.bonfigli@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived stability of cognitive status by the older adults (time frame: baseline and 6 months later). 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 NCT06302686, 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 12 Mar 2024; AzTrials last refreshed its copy on 1 Nov 2026.