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Clinical Trials in Italy / NCT07829120
Recruiting Not applicable

Multidomain Intervention Based on ICOPE

NCT07829120 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Milano Bicocca
Phase
Not applicable
Started
2025-12-01
Last updated
2026-09-18

Condition(s) studied

Intrinsic Capacity

Investigational drug(s) / intervention(s)

Multidomain intervention

Multidomain intervention: Following the in-depth assessment, each participant receives a personalized 3-month multidomain intervention plan tailored to identified IC impairments, clinical status, preferences, and social context. A multidisciplinary team provides multicomponent physical exercise based on Vivifrail for all participants, alongside targeted interventions for cognitive impairment, overt malnutrition or risk of malnutrition, depressive symptoms, sensory deficits, and social isolation. Regular medications are also reviewed using STOPP/START criteria, with recommendations communicated to the participant and primary care physician.

Study summary

FORMULA 100 is a prospective, single-arm feasibility study conducted at two Active Ageing Centers in Monza, Italy, involving community-dwelling adults aged 65 years and older. The study will test whether an Integrated Care for Older People (ICOPE)-based care pathway can be implemented in this setting.

Participants will first be screened for possible decline in intrinsic capacity (IC). Those enrolled will then undergo a multidimensional assessment and receive a personalized 3-month intervention tailored to their needs. The intervention may address physical, cognitive, nutritional, psychological, sensory, and social needs and may also include a review of medications.

Participants will be reassessed after 3 months and again after 6 months. The main study outcome is the proportion of participants who complete the 6-month follow-up. About 300 people are expected to be screened, with a target enrollment of 250 participants.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • ICOPE-based program feasibility, operationalized as the study completion rate at 6 months. — 6 months
    This retention rate is defined as the proportion of enrolled participants who complete the entire study pathway, with a prespecified feasibility target of ≥80%.

Trial sites (1)

FacilityCityRegionStatus
Active Ageing Centers (organized by Sociosfera) Monza Monza E Brianza Recruiting

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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 NCT07829120 on ClinicalTrials.gov ↗ ← All trials in Italy