A Socio-Technological Intervention in Community-Based Healthcare for Individuals With Mild Cognitive Impairment (DHEAL-COM-MCI)

NCT ID: NCT06984367

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-08
• Study Completion Date: 2025-12-31

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.

Conditions

Mild Cognitive Impairment; Older People

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

cognitive stimulation arm

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.

Group Type: EXPERIMENTAL

socio-technical intervention

Intervention Type: OTHER

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.

Control Group

Participants in the Control Group will receive a booklet containing information and activities on well-being.

Group Type: SHAM_COMPARATOR

Usual care

Intervention Type: OTHER

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.

Interventions

socio-technical intervention

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.

Intervention Type: OTHER

Usual care

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Italy

OTHER_GOV

Sponsor Role: collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberta Bevilacqua, PhD

Role: STUDY_CHAIR

IRCCS INRCA, Ancona, Italy

Locations

IRCCS INRCA Hospital

Ancona, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Anna Rita Bonfigli

Role: CONTACT

a.bonfigli@inrca.it

0718003719

Facility Contacts

Elvira Maranesi, PhD

Role: primary

e.maranesi@inrca.it

Other Identifiers

INRCA_005_2025

Identifier Type: -

Identifier Source: org_study_id