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NCT Number: NCT07829120

Multidomain Intervention Based on ICOPE

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.

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Key information

Conditions

Intrinsic Capacity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multidomain intervention

Other

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.

Primary outcomes

  1. 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%.

Secondary outcomes

  1. 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

  2. Prevalence of frailty

    Time frame: Baseline

    Baseline prevalence of frailty

  3. Adherence to multidomain interventions

    Time frame: 3 months

    Mean proportion of prescribed intervention sessions completed

  4. Participant satisfaction

    Time frame: 3 months and 6 months

    Likert-5 point questionnaire

Other outcomes

  1. 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)

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Cristina Ferrara, Medical doctor and PhD

CONTACT

[email protected]

+39 0392339719

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Collaborators

  • Cariplo Foundation

Registry information

Official study title

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

Acronym: FORMULA 100

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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