An interventional study of Multidomain intervention in Intrinsic Capacity, sponsored by University of Milano Bicocca. Recruiting at 1 site in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by University of Milano Bicocca · Not applicable, Interventional, and Other
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.
University of Milano Bicocca is the lead sponsor of 126 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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
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
Plan to share: Undecided — The datasets that will be produced during the study will be available on reasonable request to the Principal Investigator.
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