Multidomain Intervention Based on ICOPE (FORMULA 100)

September 14, 2026 updated by: University of Milano Bicocca

FORMULA 100: an ICOPE-based Multidomain Intervention to Promote Active and Healthy Ageing.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Monza E Brianza
      • Monza, Monza E Brianza, Italy, 20900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multidomain intervention
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICOPE-based program feasibility, operationalized as the study completion rate at 6 months.
Time Frame: 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%.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of IC-domain impairments
Time Frame: Baseline
Baseline prevalence of impairment in each IC domain, as identified through the first-level screening and further confirmed through the in-depth assessment
Baseline
Prevalence of frailty
Time Frame: Baseline
Baseline prevalence of frailty
Baseline
Adherence to multidomain interventions
Time Frame: 3 months
Mean proportion of prescribed intervention sessions completed
3 months
Participant satisfaction
Time Frame: 3 months and 6 months
Likert-5 point questionnaire
3 months and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
IC domain-specific measures changes
Time Frame: Baseline to 3 month and 6 month
Longitudinal changes in IC-domain specific measures (in-depth multidimensional assessment)
Baseline to 3 month and 6 month
Falls, emergency department visits, hospitalizations, and vital status
Time Frame: 3 month and 6 month
Number of falls, emergency department visits, hospitalizations, and vital status at follow-up visits
3 month and 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Collaborators

Cariplo Foundation

Investigators

  • Principal Investigator: Giuseppe Bellelli, Medical doctor, full professor, University of Milano-Bicocca, IRCCS Foundation San Gerardo dei Tintori

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

September 14, 2026

First Submitted That Met QC Criteria

September 14, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • N. 0447865 (20/10/2025)
  • Ref. 2024-2810 (28/01/2025) (Other Grant/Funding Number: Cariplo Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The datasets that will be produced during the study will be available on reasonable request to the Principal Investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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