FORMULA 100: an ICOPE-based Multidomain Intervention to Promote Active and Healthy Ageing.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Milano Bicocca
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- ICOPE-based program feasibility, operationalized as the study completion rate at 6 months.
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Multidomain intervention
Intervention: Multidomain intervention (Other)
Outcomes
Primary Outcomes
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
- Prevalence of frailty(Baseline)
- Prevalence of IC-domain impairments(Baseline)
- Adherence to multidomain interventions(3 months)
- Participant satisfaction(3 months and 6 months)