Mild Cognitive ImpairmentDHEAL-COM-MCINCT06984367
A Socio-Technological Intervention in Community-Based Healthcare for Individuals With Mild Cognitive Impairment (DHEAL-COM-MCI)
A study testing socio-technical intervention in people with Mild Cognitive Impairment and Older People, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
Trial summary
The objectives of the intervention are to counteract the progression of cognitive decline, enhance the intrinsic abilities of users and support the well-being of elderly people with mild cognitive impairment (MCI) through a socio-technical intervention that includes cognitive stimulation, technology and robotics. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Older People
- What is being tested?
- socio-technical intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 8 Apr 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- diagnosis of Mild Cognitive Impairment;
- MoCA ranged 21 - 27;
- Geriatric Depression Scale 5 items (GDS-5items) ≤ 1
Who cannot join
- Use of active implantable or non-implantable medical devices;
- Nickel allergy;
- Myocardial infarction or stroke within 6 months;
- Painful arthritis, spinal stenosis, amputation, painful foot lesions, or neuropathy that limits balance and mobility;
- Uncontrolled hypertension;
- Pacemaker or implantable cardioverter defibrillator;
- Metastatic cancer or immunosuppressive therapy;
- Significant vision or hearing disturbances.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS INRCA Hospital
Ancona, 60127
Elvira Maranesi, PhD, e.maranesi@inrca.it
About this study
The objectives of the intervention are to counteract the progression of cognitive decline, enhance the intrinsic abilities of users and support the well-being of elderly people with mild cognitive impairment (MCI) through a socio-technical intervention that includes cognitive stimulation, technology and robotics.
Read the detailed description
The DHEAL-COM-MCI trial is a feasibility pilot with single-blind Randomized Controlled Trial type experimental design. Fifty older adults with Mild Cognitive Impairment (MCI) will be recruited for the study and randomized into two groups: the experimental group, that will perform a stimulation using a specific software, and the control group. Patients in the control group will be offered activities to perform at home, with the same frequency, in line with the usual care activities already proposed by the Neurology Unit. In order to follow the cognitive training, the participants of the Experimental group will receive the following technological devices:
- the software BRAINER, a web platform dedicated to cognitive rehabilitation exercises over 5 different domains such as complex attention, executive function, learning and memory, language and perceptual- motor skills. A dedicated tablet will be provided to the participants to use the Brainer;
- the social robot NAOv6, a fully programmable robot that can interact through its sensors and speech capabilities (i.e RGB camera, ultrasonic proximity sensors on the chest, two microphones, and tactile sensors on the head, hands, feet, and shoulders). NAO is also able to move thanks to multiple joints and actuators, and perform multiple and very complex movements. It can also understand people's language and emotions, as well as respond correctly to any request by speaking and making appropriate gestures;
- In addition, as both NAO and the BRAINER need an internet connection, a webpocket equipped with a SIM card will be given to the user, to allow the 4G connection of the devices. In this way, the functioning of the equipment is guaranteed for the whole period of testing independently of the user's private home/mobile Wi-Fi.
Participants in the Control Group (CG) will receive a booklet containing information and activities on well-being (Appendix A). They will be invited to do whatever they wish with the information booklet and the proposed exercises.
The primary endpoint of the study is to evaluate the perceived stability of the cognitive abilities of older adults with MCI after 12-week of intervention through the MoCA (Montreal Cognitive Assessment) scale.
- Conditions
- Mild Cognitive Impairment, Older People
- Being tested
- socio-technical intervention, Usual care
- Keywords
- social assistive robotics, technology acceptance
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socio-technical interventionOther
A daily cognitive stimulation at home with specific software (Brainer) and 1 group session per week. Furthermore, each participant will receive the NAO robot at home.
Usual careOther
The subjects will receive a booklet containing information and activities on well-being. They will be invited to do whatever they wish with the information booklet and the proposed exercises, as they would do outside the framework of the experiment. In any case, they will be free to read and do the proposed exercises.
| Study group | Role | What they receive |
|---|---|---|
| cognitive stimulation arm | Experimental | Daily cognitive stimulation at home with specific software (Brainer) and 1 group session per week, for a total of 12 weeks. Furthermore, each participant will receive the NAO robot at home for a month. Receives: Other: socio-technical intervention |
| Control Group | Sham comparator | Participants in the Control Group will receive a booklet containing information and activities on well-being. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive capabilities of older people with MCI
It will be assessed through the Montreal Cognitive Assessment (MoCA). The MoCA is a one-page 30-point test administered in approximately 10 minutes. 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). A score of 26 or above is typically considered within the normal range; scores between 18 and 25 may suggest mild cognitive impairment; scores between 10 and 17 may indicate moderate cognitive impairment; scores below 10 may indicate severe cognitive impairment.
Measured: at baseline and 12 weeks later
Secondary outcomes (3)
Fragility
It will be assessed by the Clinical Frailty Scale (CFS). This 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: at baseline and 12 weeks later
Health related quality of life
The health related quality of life will be evaluated by EQ-5D-5L. The 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 participant is asked to indicate his/her health status by ticking the box corresponding to the most appropriate statement in each of the five dimensions. The numbers from the five dimensions can be combined into a 5-digit number that describes the health status of the participant. A person reporting "no problems" in all five dimensions would have a health state profile of 11111 (representing full health).
A person with "slight problems with mobility (2), no problems with self-care (1), moderate problems with usual activities (3), severe pain/discomfort (4), and no anxiety/depression (1)" would have a health state profile of 21341.
The "worst possible health state" would be 55555.
Measured: at baseline and 12 weeks later
Psychological Wellbeing
The Psychological Wellbeing Scale (PWB) consists of several subscales (self acceptance, positive relationships with others, autonomy, environmental mastery, purpose in life, and personal growth) that measures six aspects of wellbeing and happiness. Individuals respond to the 42 items. Each of the 42 items is rated on a 7-point Likert scale, ranging from 1 ("Strongly disagree") to 7 ("Strongly agree"). The total score can range from 42 to 294, with higher scores indicating greater overall psychological well-being.
Measured: at baseline and 12 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start8 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Sponsor
- Investigators
- Roberta Bevilacqua, PhD, Study chair, IRCCS INRCA, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984367
- Sponsor's protocol ID
- INRCA_005_2025
- Acronym
- DHEAL-COM-MCI
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Socio-Technological Intervention in Community-Based Healthcare for Individuals With Mild Cognitive Impairment (DHEAL-COM-MCI)
- ClinicalTrials.gov ID
- NCT06984367
- Acronym / sponsor ID
- DHEAL-COM-MCI / INRCA_005_2025
- Conditions
- Mild Cognitive Impairment, Older People
- Keywords
- social assistive robotics, technology acceptance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 May 2025 (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 intervention are to counteract the progression of cognitive decline, enhance the intrinsic abilities of users and support the well-being of elderly people with mild cognitive impairment (MCI) through a socio-technical intervention that includes cognitive stimulation, technology and robotics.
Detailed description
The DHEAL-COM-MCI trial is a feasibility pilot with single-blind Randomized Controlled Trial type experimental design. Fifty older adults with Mild Cognitive Impairment (MCI) will be recruited for the study and randomized into two groups: the experimental group, that will perform a stimulation using a specific software, and the control group. Patients in the control group will be offered activities to perform at home, with the same frequency, in line with the usual care activities already proposed by the Neurology Unit. In order to follow the cognitive training, the participants of the Experimental group will receive the following technological devices:
- the software BRAINER, a web platform dedicated to cognitive rehabilitation exercises over 5 different domains such as complex attention, executive function, learning and memory, language and perceptual- motor skills. A dedicated tablet will be provided to the participants to use the Brainer;
- the social robot NAOv6, a fully programmable robot that can interact through its sensors and speech capabilities (i.e RGB camera, ultrasonic proximity sensors on the chest, two microphones, and tactile sensors on the head, hands, feet, and shoulders). NAO is also able to move thanks to multiple joints and actuators, and perform multiple and very complex movements. It can also understand people's language and emotions, as well as respond correctly to any request by speaking and making appropriate gestures;
- In addition, as both NAO and the BRAINER need an internet connection, a webpocket equipped with a SIM card will be given to the user, to allow the 4G connection of the devices. In this way, the functioning of the equipment is guaranteed for the whole period of testing independently of the user's private home/mobile Wi-Fi.
Participants in the Control Group (CG) will receive a booklet containing information and activities on well-being (Appendix A). They will be invited to do whatever they wish with the information booklet and the proposed exercises.
The primary endpoint of the study is to evaluate the perceived stability of the cognitive abilities of older adults with MCI after 12-week of intervention through the MoCA (Montreal Cognitive Assessment) scale.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive stimulation arm | Experimental | Other: socio-technical interventionDaily cognitive stimulation at home with specific software (Brainer) and 1 group session per week, for a total of 12 weeks. Furthermore, each participant will receive the NAO robot at home for a month. |
| Control Group | Sham comparator | Other: Usual careParticipants in the Control Group will receive a booklet containing information and activities on well-being. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- diagnosis of Mild Cognitive Impairment;
- MoCA ranged 21 - 27;
- Geriatric Depression Scale 5 items (GDS-5items) ≤ 1
Key exclusion criteria (8 listed)
- Use of active implantable or non-implantable medical devices;
- Nickel allergy;
- Myocardial infarction or stroke within 6 months;
- Painful arthritis, spinal stenosis, amputation, painful foot lesions, or neuropathy that limits balance and mobility;
- Uncontrolled hypertension;
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 |
|---|---|---|
| socio-technical interventionA daily cognitive stimulation at home with specific software (Brainer) and 1 group session per week. Furthermore, each participant will receive the NAO robot at home. | Other | cognitive stimulation arm |
| Usual careThe subjects will receive a booklet containing information and activities on well-being. They will be invited to do whatever they wish with the information booklet and the proposed exercises, as they would do outside the framework of the experiment. In any case, they will be free to read and do the proposed exercises. | Other | Control Group |
Primary outcome
cognitive capabilities of older people with MCI
Time frame: at baseline and 12 weeks later
It will be assessed through the Montreal Cognitive Assessment (MoCA). The MoCA is a one-page 30-point test administered in approximately 10 minutes. 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). A score of 26 or above is typically considered within the normal range; scores between 18 and 25 may suggest mild cognitive impairment; scores between 10 and 17 may indicate moderate cognitive impairment; scores below 10 may indicate severe cognitive impairment.
3 secondary outcomes
Fragility
Time frame: at baseline and 12 weeks later
Health related quality of life
Time frame: at baseline and 12 weeks later
Psychological Wellbeing
Time frame: at baseline and 12 weeks later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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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.
Roberta Bevilacqua, PhD study chair
IRCCS INRCA, Ancona, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing socio-technical intervention in people with Mild Cognitive Impairment and Older People, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
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 8 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: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
cognitive capabilities of older people with MCI (time frame: at baseline and 12 weeks later). 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 30 May 2025.