Multidomain Intervention Based on ICOPE

NCT07829120 | Recruiting

• 2 other identifiers: N. 0447865 (20/10/2025)Ref. 2024-2810 (28/01/2025)
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrinsic Capacity

Keywords

intrinsic capacity; multidomain intervention; older adults

Outcome Measures

Primary Outcomes (1)

• 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%.

  6 months

Secondary Outcomes (4)

• Prevalence of IC-domain impairments

  Baseline

• Prevalence of frailty

  Baseline

• Adherence to multidomain interventions

  3 months

• Participant satisfaction

  3 months and 6 months

Other Outcomes (2)

• IC domain-specific measures changes

  Baseline to 3 month and 6 month

• Falls, emergency department visits, hospitalizations, and vital status

  3 month and 6 month

Study Arms (1)

Multidomain intervention

EXPERIMENTAL

Other: Multidomain intervention

Interventions

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.

Multidomain intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milano Bicocca: lead
• Cariplo Foundation: collaborator

Study Sites (1)

Active Ageing Centers (organized by Sociosfera)

Monza, Monza E Brianza, 20900, Italy

RECRUITING

Related Publications (8)

• Ferrara MC, Perez LM, Sole AR, Villa-Garcia L, Ars J, Soto-Bagaria L, Bellelli G, Cesari M, Enfedaque MB, Inzitari M. Sustained improvement of intrinsic capacity in community-dwelling older adults: The +AGIL Barcelona multidomain program. J Intern Med. 2023 Dec;294(6):730-742. doi: 10.1111/joim.13710. Epub 2023 Aug 21.

  PMID: 37574781 BACKGROUND

• Merchant RA, Liu Y, Tan LF, Yeo L, Sandrasageran S, Tay YK, Seet A, Chua L, Tan WM, Vellas B. Community-Based ICOPE Screening Identifies Intrinsic Capacity Impairment and Supports Integrated Health and Social Care. J Am Med Dir Assoc. 2026 Aug 4;27(10):106414. doi: 10.1016/j.jamda.2026.106414. Online ahead of print.

  PMID: 42551140 BACKGROUND

• Yan Wang N, Liu X, Kong X, Sumi Y, Chhetri JK, Hu L, Zhu M, Kang L, Liang Z, Ellis JW, Shi L. Implementation and impact of the World Health Organization integrated care for older people (ICOPE) program in China: a randomised controlled trial. Age Ageing. 2024 Jan 2;53(1):afad249. doi: 10.1093/ageing/afad249.

  PMID: 38251736 BACKGROUND

• Tavassoli N, Piau A, Berbon C, De Kerimel J, Lafont C, De Souto Barreto P, Guyonnet S, Takeda C, Carrie I, Angioni D, Paris F, Mathieu C, Ousset PJ, Balardy L, Voisin T, Sourdet S, Delrieu J, Bezombes V, Pons-Pretre V, Andrieu S, Nourhashemi F, Rolland Y, Soto ME, Beard J, Sumi Y, Araujo Carvalho I, Vellas B. Framework Implementation of the INSPIRE ICOPE-CARE Program in Collaboration with the World Health Organization (WHO) in the Occitania Region. J Frailty Aging. 2021;10(2):103-109. doi: 10.14283/jfa.2020.26.

  PMID: 33575698 BACKGROUND

• Malkowski OS, Davis-Plourde K, Western MJ, Gill TM. Association between intrinsic capacity and disability before death among older adults: a decedent cohort study. Lancet Healthy Longev. 2026 May;7(5):100854. doi: 10.1016/j.lanhl.2026.100854. Epub 2026 Jun 9.

  PMID: 42263724 BACKGROUND

• Cesari M, Canevelli M, Amuthavalli Thiyagarajan J, Arai H, Assantachai P, Chan P, Chhetri JK, Ferriolli E, Geffen L, Gregson CL, Guaraldi G, Gutierrez Robledo LM, Hammami S, Jang H, Kalula S, Mathur A, Merchant RA, Oliveira D, Perracini MR, Petrovic M, Polidori-Nelles MC, Rodriguez Manas L, Rowe JW, Sabzwari S, Sadana R, Sumi Y, Tomarevska O, Vellas B, Visvanathan R, Woo J, Martin FC. Frailty and intrinsic capacity: integrating complementary concepts to promote healthy ageing and transformation of care. Age Ageing. 2026 May 4;55(5):afag138. doi: 10.1093/ageing/afag138.

  PMID: 42166522 BACKGROUND

• Sanchez-Sanchez JL, Lu WH, Gallardo-Gomez D, Del Pozo Cruz B, de Souto Barreto P, Lucia A, Valenzuela PL. Association of intrinsic capacity with functional decline and mortality in older adults: a systematic review and meta-analysis of longitudinal studies. Lancet Healthy Longev. 2024 Jul;5(7):e480-e492. doi: 10.1016/S2666-7568(24)00092-8.

  PMID: 38945130 BACKGROUND

• Sum G, Lau LK, Jabbar KA, Lun P, George PP, Munro YL, Ding YY. The World Health Organization (WHO) Integrated Care for Older People (ICOPE) Framework: A Narrative Review on Its Adoption Worldwide and Lessons Learnt. Int J Environ Res Public Health. 2022 Dec 22;20(1):154. doi: 10.3390/ijerph20010154.

  PMID: 36612480 BACKGROUND

Study Officials

• Giuseppe Bellelli, Medical doctor, full professor

  University of Milano-Bicocca, IRCCS Foundation San Gerardo dei Tintori

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Cristina Ferrara, Medical doctor and PhD

CONTACT

+39 0392339719; mariacristina.ferrara@unimib.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-arm feasibility study of a multidomain intervention conducted at two Active Ageing Centers (AACs) in Monza, Lombardy (Italy).

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

IT (1)