Multidomain Intervention Based on ICOPE

University of Milano Bicocca250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

250

Conditions

Intrinsic Capacity

Interventions

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

ICOPE-based program feasibility, operationalized as the study completion rate at 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%.

Time frame: 6 months

Secondary Outcomes

Prevalence of IC-domain impairments

Baseline prevalence of impairment in each IC domain, as identified through the first-level screening and further confirmed through the in-depth assessment

Time frame: Baseline

Prevalence of frailty

Baseline prevalence of frailty

Time frame: Baseline

Adherence to multidomain interventions

Mean proportion of prescribed intervention sessions completed

Time frame: 3 months

Participant satisfaction

Likert-5 point questionnaire

Time frame: 3 months and 6 months