Personalized multidomain care pathway for older adults with Intrinsic Capacity decline
Official title: FORMULA 100: an ICOPE-based Multidomain Intervention to Promote Active and Healthy Ageing.
Run by University of Milano Bicocca · NCT07829120 · Data updated 2026-11-12
This study tests a personalized, ICOPE-based multidomain care plan for community-dwelling adults aged 65 and older to see if a 6-month program can be completed and sustained.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | University of Milano Bicocca Academic / other |
| Locations | 1 site (Monza, Monza E Brianza) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | September 18, 2026 |
| Trial ID | NCT07829120 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 65 and older attending the participating Active Ageing Centers with impairment in at least one intrinsic capacity domain and able to walk independently and communicate with the research team.
✕Probably not a fit
Individuals with conditions that preclude participation in the screening or safe participation, such as severe dementia or end-stage illnesses, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
BASIC: This is a prospective, single-arm feasibility study conducted at two Active Ageing Centers in Monza, Italy, enrolling community-dwelling adults aged 65 and older who show impairment in at least one domain of intrinsic capacity. Participants undergo a multidimensional assessment and receive a personalized 3-month intervention addressing physical, cognitive, nutritional, psychological, sensory, and social needs, with a medication review as needed. They are reassessed at 3 months and again at 6 months, with the main outcome being the proportion who complete the 6-month follow-up. About 300 people are expected to be screened and 250 enrolled. The goal is to determine whether implementing an Integrated Care for Older People (ICOPE)-based care pathway is feasible in this setting.
Why it matters
Potential benefit: If successful, participants may experience improvements or stabilization in multiple domains of intrinsic capacity through a tailored, coordinated care plan.
How similar studies have gone: Previous work suggests multidomain, person-centered interventions can be feasible in older populations, but this specific ICOPE-based, two-center feasibility study is novel in design and setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 65 years * Attendance at one of the Active Ageing Centers participating in the project * Evidence of impairment in at least one key domain of intrinsic capacity, as identified through the first-level ICOPE screening * Ability to walk independently (with or without a walking aid) * Ability to communicate and cooperate with the research team Exclusion Criteria: * Clinical conditions precluding completion of the first-level ICOPE screening or safe participation in the study, including severe dementia, bilateral blindness, end-stage diseases (e.g., Child-Pugh class C liver cirrhosis, stage 5 chronic kidney disease, chronic obstructive pulmonary disease Global Initiative for Chronic Obstructive Lung Disease group D, end-stage heart failure, or advanced cancer) * Concurrent participation in another clinical study * Refusal or inability to provide written informed consent
Where it's running
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Active Ageing Centers (organized by Sociosfera)
Monza, Monza E Brianza, Italy Recruiting
Study contacts
- Principal investigator: Giuseppe Bellelli, Medical doctor, full professor — University of Milano-Bicocca, IRCCS Foundation San Gerardo dei Tintori
- Study coordinator: Maria Cristina Ferrara, Medical doctor and PhD
- Email: mariacristina.ferrara@unimib.it
- Phone: +39 0392339719
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.