Actively Recruiting
A Socio-Technological Intervention in Community-Based Healthcare for Individuals With Mild Cognitive Impairment (DHEAL-COM-MCI)
Led by Istituto Nazionale di Ricovero e Cura per Anziani · Updated on 2025-05-30
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Istituto Nazionale di Ricovero e Cura per Anziani
Lead Sponsor
M
Ministry of Health, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a socio-technical intervention to slow down cognitive decline, improve abilities, and support well-being in elderly people with mild cognitive impairment (MCI). This pilot study uses a single-blind randomized controlled design involving 50 older adults with MCI to assess the effects of cognitive stimulation combined with technology and robotics. Participants are randomly assigned to two groups. The experimental group will use the BRAINER software on a tablet daily for cognitive exercises targeting attention, memory, language, and motor skills, plus one weekly group session for 12 weeks. They will also receive the NAOv6 social robot at home for one month, which can interact through speech, movements, and sensors. The control group will receive a booklet with well-being information and activities to perform at home with the same frequency as usual care. During the study, participants will be assessed using the Montreal Cognitive Assessment (MoCA) scale at the start and after 12 weeks to measure cognitive stability. Additional evaluations include frailty, health-related quality of life, and psychological well-being. The intervention period lasts 12 weeks, with home-based activities supported by technology and regular monitoring of cognitive and health outcomes.
CONDITIONS
Brief Title
A Socio-Technological Intervention in Community-Based Healthcare for Individuals With Mild Cognitive Impairment (DHEAL-COM-MCI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of mild cognitive impairment
- Montreal Cognitive Assessment (MoCA) score between 21 and 27
- Geriatric Depression Scale (5 items) score of 1 or less
You will not qualify if you...
- Use of active implantable or non-implantable medical devices
- Nickel allergy
- Myocardial infarction or stroke within the past 6 months
- Painful arthritis, spinal stenosis, amputation, painful foot lesions, or neuropathy limiting balance or mobility
- Uncontrolled hypertension
- Presence of pacemaker or implantable cardioverter defibrillator
- Metastatic cancer or receiving immunosuppressive therapy
- Significant vision or hearing disturbances
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants will be randomized into two groups. The experimental group will perform daily cognitive stimulation at home with a specific software (Brainer) and attend 1 group session per week for 12 weeks. They will also receive the NAO robot at home for one month. The control group will receive a booklet containing information and activities on well-being to perform at home as they wish.
Weekly group sessions for 12 weeks; daily home activities
Trial Site Locations
Total: 1 location
1
IRCCS INRCA Hospital
Ancona, Italy, 60127
Actively Recruiting
Research Team
A
Anna Rita Bonfigli
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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