Multidomain Intervention Based on ICOPE

ConditionIntrinsic Capacity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age65+

SponsorUniversity of Milano Bicocca

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Multidomain intervention
Other 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.

Treatment groups

250 Participants

are divided into 1 treatment group

Group A: Multidomain interventionExperimental treatment 1 intervention

Trial 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

Other outcomes

IC domain-specific measures changes

Longitudinal changes in IC-domain specific measures (in-depth multidimensional assessment)

Time frame

Baseline to 3 month and 6 month

Falls, emergency department visits, hospitalizations, and vital status

Number of falls, emergency department visits, hospitalizations, and vital status at follow-up visits

Time frame

3 month and 6 month

Sponsors and contacts

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University of Milano Bicocca

Lead sponsor

Cariplo Foundation

Collaborator

Source ClinicalTrials.gov

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