ItaliaN Study Testing Tailored Multidomain Interventions
To Prevent Functional and Cognitive Decline in Older Adults Living in the Community
Led by University of Milano Bicocca · Updated on 2025-07-29
1340
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating whether a tailored multi-domain intervention can help prevent functional and cognitive decline in older adults considered at risk. This interventional study focuses on community-dwelling adults aged 60 and older who show mild to moderate vulnerability and increased risk of developing dementia based on various health and lifestyle factors. The interventions aim to address multiple areas including physical health, nutrition, cognition, and social well-being to support healthy aging.
Participants in the active intervention group will receive a combination of physical exercise, a Mediterranean diet plan, cognitive training, regular medical check-ups, oral hygiene counseling, sleep hygiene support, management of cardiovascular and metabolic risk factors, medication adjustments, and encouragement of social interactions. These activities will be supported and monitored through wearable devices, digital tools, and apps. The control group will receive standard health advice through apps and a one-time counseling session, reflecting usual clinical care.
The study includes an initial screening visit involving detailed assessments of cognitive function, physical performance, frailty, and dementia risk factors. Eligible participants will then be followed for 18 months, with baseline and three follow-up visits at 6, 12, and 18 months to collect data on various cognitive, physical, psychological, and quality of life measures. Researchers will monitor outcomes such as neuropsychological test scores, physical performance, daily living activities, mood, sleep quality, nutrition, and incidence of mild cognitive impairment or dementia. The total participation period spans approximately two years including observation of health events like falls and hospital visits.
CONDITIONS
Brief Title
ItaliaN Study With Tailored Multidomain Interventions to Prevent Functional and Cognitive Decline in Community-dwelling Older Adults
Research Team
C
Carlo Ferrarese
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Mild to moderate vulnerability (Primary Care Frailty Index score between 0.07 and 0.21)
Cardiovascular risk factors, Ageing and Incidence of Dementia (CAIDE) score greater than 6
Clinical Dementia Rating (CDR) of 0.5 or less
Increased risk of developing dementia by family history (at least one family member with dementia) and/or at least one modifiable risk factor with a Lifestyle Index of 2 or higher
Physical activity less than 2.5 hours per week (intense enough to cause sweating and breathlessness) counts as one risk factor
Diet with less than 5 servings of fruits and vegetables per day counts as one risk factor
Diet with less than 2 servings of fish per week counts as one risk factor
Hypertension diagnosed by a physician, on medication, or with blood pressure over 140/90 mmHg counts as one risk factor
Diabetes (type 1 or 2) diagnosed by a physician, on medication, or with HbA1C 7% or higher in the past 6 months counts as one risk factor
Sleep disturbances, depressive symptoms, or mental/physical stress for at least 1 month that affect daily life counts as one risk factor
Body mass index (BMI) of 25 or higher counts as one risk factor
Alcohol intake over 21 units per week counts as one risk factor
Ability to give informed consent voluntarily
You will not qualify if you...
Diagnosis of dementia or suspected dementia after screening
Clinical Dementia Rating (CDR) greater than 0.5
Living in residential facilities for the elderly
Inability to consent or actively participate in study activities
Any condition preventing safe involvement or cooperation, such as serious neurological or psychiatric disorders, recent brain hemorrhage, history of head trauma with lasting neurological effects, known brain abnormalities, active substance abuse, uncontrolled major organ disease, recent cancer except certain skin or prostate cancers, serious blood abnormalities, severe loss of vision, hearing, or communication abilities
Participation in other clinical trials
High performance on memory screening tests (RAVL-T immediate score above 48, RAVL-T delayed score above 10)
Planned moves away from the municipality lasting more than 2 weeks during the study period
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial through a multi-faceted evaluation of cognitive function, physical and functional efficiency, and cardiovascular and cognitive decline risk factors.
1 visit (in-person)
Treatment
Duration - 18 months
Eligible participants receive tailored multidomain interventions including physical exercise, Mediterranean diet-based nutrition, cognitive training, oral hygiene counseling, sleep quality assessment and advice, control of cardiovascular and metabolic risk factors, pharmacological evaluation, and social activity encouragement. Participants in the active intervention arm attend group and individual sessions and use digital tools and wearable devices. Those in the self-administered intervention arm receive counseling and health advice via dedicated apps and portals.
1 baseline visit and 3 follow-up visits at 6, 12, and 18 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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