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

NCT06984367 | Recruiting

• 1 other identifier: INRCA_005_2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Older People

Keywords

social assistive robotics; technology acceptance

Outcome Measures

Primary Outcomes (1)

• 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.

  at baseline and 12 weeks later

Secondary Outcomes (3)

• Fragility

  at baseline and 12 weeks later

• Health related quality of life

  at baseline and 12 weeks later

• Psychological Wellbeing

  at baseline and 12 weeks later

Study Arms (2)

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.

Other: socio-technical intervention

Control Group

SHAM COMPARATOR

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

Other: Usual care

Interventions

socio-technical intervention 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.

cognitive stimulation arm

Usual care 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.

Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead
• Ministry of Health, Italy: collaborator

Study Sites (1)

IRCCS INRCA Hospital

Ancona, 60127, Italy

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Roberta Bevilacqua, PhD

  IRCCS INRCA, Ancona, Italy

  STUDY CHAIR

Central Study Contacts

Anna Rita Bonfigli

CONTACT

0718003719; a.bonfigli@inrca.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: April 8, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)