Multidomain Intervention Based on ICOPE (FORMULA 100)
14. september 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
250
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Maria Cristina Ferrara, Medical doctor and PhD
- Telefonnummer: +39 0392339719
- E-mail: mariacristina.ferrara@unimib.it
Studiesteder
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Monza E Brianza
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Monza, Monza E Brianza, Italien, 20900
- Rekruttering
- Active Ageing Centers (organized by Sociosfera)
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Kontakt:
- Sociosfera president
- Telefonnummer: +39 3408747301
- E-mail: a.lex@sociosfera.it
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Kontakt:
- Manuela Grimoldi
- E-mail: m.grimoldi@sociosfera.it
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Multidomain intervention
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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ICOPE-based program feasibility, operationalized as the study completion rate at 6 months.
Tidsramme: 6 months
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This retention rate is defined as the proportion of enrolled participants who complete the entire study pathway, with a prespecified feasibility target of ≥80%.
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6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Prevalence of IC-domain impairments
Tidsramme: Baseline
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Baseline prevalence of impairment in each IC domain, as identified through the first-level screening and further confirmed through the in-depth assessment
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Baseline
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Prevalence of frailty
Tidsramme: Baseline
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Baseline prevalence of frailty
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Baseline
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Adherence to multidomain interventions
Tidsramme: 3 months
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Mean proportion of prescribed intervention sessions completed
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3 months
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Participant satisfaction
Tidsramme: 3 months and 6 months
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Likert-5 point questionnaire
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3 months and 6 months
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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IC domain-specific measures changes
Tidsramme: Baseline to 3 month and 6 month
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Longitudinal changes in IC-domain specific measures (in-depth multidimensional assessment)
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Baseline to 3 month and 6 month
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Falls, emergency department visits, hospitalizations, and vital status
Tidsramme: 3 month and 6 month
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Number of falls, emergency department visits, hospitalizations, and vital status at follow-up visits
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3 month and 6 month
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Giuseppe Bellelli, Medical doctor, full professor, University of Milano-Bicocca, IRCCS Foundation San Gerardo dei Tintori
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. december 2025
Primær færdiggørelse (Anslået)
31. marts 2027
Studieafslutning (Anslået)
31. marts 2027
Datoer for studieregistrering
Først indsendt
14. september 2026
Først indsendt, der opfyldte QC-kriterier
14. september 2026
Først opslået (Faktiske)
18. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- N. 0447865 (20/10/2025)
- Ref. 2024-2810 (28/01/2025) (Andet bevillings-/finansieringsnummer: Cariplo Foundation)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
The datasets that will be produced during the study will be available on reasonable request to the Principal Investigator.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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