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Recruiting Not applicable

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

NCT06984367 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-04-08
Last updated
2025-05-30

Condition(s) studied

Mild Cognitive ImpairmentOlder People

Investigational drug(s) / intervention(s)

socio-technical interventionUsual care

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • cognitive capabilities of older people with MCI — 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.

Trial sites (1)

FacilityCityRegionStatus
IRCCS INRCA Hospital Ancona Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06984367 on ClinicalTrials.gov ↗ ← All trials in Italy