Clinical trial NCT06984367: A Socio-Technological Intervention in Community-Based Healthcare for Individuals With Mild Cognitive Impairment (DHEAL-COM-MCI)
Official title: A Socio-Technological Intervention in Community-Based Healthcare for Individuals With Mild Cognitive Impairment (DHEAL-COM-MCI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Older People
Keywords: social assistive robotics
technology acceptance
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2025-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* diagnosis of Mild Cognitive Impairment;
* MoCA ranged 21 - 27;
* Geriatric Depression Scale 5 items (GDS-5items) ≤ 1

Exclusion Criteria:

* 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.

Primary outcomes:
measure: cognitive capabilities of older people with MCI
timeFrame: at baseline and 12 weeks later
Secondary outcomes:
measure: Fragility
timeFrame: at baseline and 12 weeks later
measure: Health related quality of life
timeFrame: at baseline and 12 weeks later
measure: Psychological Wellbeing
timeFrame: at baseline and 12 weeks later
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
affiliation: IRCCS INRCA, Ancona, Italy
name: Roberta Bevilacqua, PhD
role: STUDY_CHAIR
References: