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Background <p>Hospitalisation frequently leads to hospital-acquired disability in older adults, with subsequent functional decline and loss of independence. However, the potential role of multidomain interventions (MDIs) integrating physical, nutritional and cognitive components, supported by digital technologies, remains largely unexplored in the acute care setting. OPTIMAge-IT therefore aims to evaluate the effect of a technology-supported MDI on motor function at hospital discharge and its feasibility in the post-discharge phase among frail older adults.</p> Methods <p>OPTIMAge-IT is an ongoing, pragmatic, multicentre, cluster-randomised controlled trial conducted in eight Italian Acute Geriatric Units. Adults aged ≥ 70&#xa0;years admitted from the Emergency Department with mild-to-moderate frailty are enrolled consecutively and allocated by centre to usual care or a structured, multidisciplinary, technology-supported MDI. The intervention starts after clinical stabilisation and continues for 12&#xa0;weeks post-discharge, supported by a tracker and a tablet. The MDI includes Vivifrail-based physical exercise, computerised cognitive training (BrainHQ), nutritional counselling, health education, medication review, and promotion of social engagement. The primary endpoint is change in Short Physical Performance Battery at hospital discharge. Secondary endpoints include feasibility of the intervention and its home continuation (adherence, usability and retention), as well as the effect of the MDI on in-hospital and post-discharge outcomes. Follow-up assessments are performed at 3 and 6&#xa0;months in the intervention arm and at 6&#xa0;months in the control arm; blood biomarkers are collected at discharge and at 6&#xa0;months.</p> Discussion <p>OPTIMAge-IT will provide evidence on the feasibility and clinical value of a technology-supported MDI to prevent hospital-acquired disability and promote functional status in frail older adults. Findings may inform the development of scalable, person-centred post-hospital care models.</p> Trial registration <p>NCT06611228 (<a href="https://clinicaltrials.gov/study/NCT06611228">https://clinicaltrials.gov/study/NCT06611228</a>; 2025–01-08).</p>

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Pragmatic cluster-randomised trial of a multidomain intervention to prevent hospital-acquired disability: the OPTIMAge-IT study protocol

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  • 发表日期：

    2026年6月23日

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  • Chukwuma Okoye,
  • Maria Cristina Ferrara,
  • Beatrice Tonus,
  • Wenxiang Guo,
  • Elena Page,
  • Eleonora Cucini,
  • Martina Marelli,
  • Alberto Finazzi,
  • Elena Pinardi,
  • Filippo Fimognari,
  • Carmen Ruberto,
  • Paola Palestini,
  • Roberta Daini,
  • Francesca Gasparini,
  • Stefano Calciolari,
  • Eleonora Pagan,
  • Luca Cuffaro,
  • Federico Emanuele Pozzi,
  • Gessica Sala,
  • Andrea Corsonello,
  • Fabio Guerini,
  • Agostino Virdis,
  • Alessandra Marengoni,
  • Andrea Ungar,
  • Antonella Zambon,
  • Carlo Ferrarese,
  • Giuseppe Bellelli,
  • Emma Esposito,
  • Anna Vanoncini,
  • Flavia Sandi,
  • Greta Tavecchi,
  • Lorenzo Lodovici,
  • Serena Bertocchi,
  • Paola Negri,
  • Luca Valsecchi,
  • Maria Chiara De Ponti,
  • Valeria Ortu,
  • Lucia Ferrara,
  • Roberto Galletti,
  • Sara Pegoraro,
  • Alessandra Grossi,
  • Alessandra Torelli,
  • Linda Milani,
  • Roberto Lucifora,
  • Marta Aber Rizzo,
  • Martina Manna,
  • Alberto Zucchelli,
  • Gianluca Bianco,
  • Pasquale Amarante,
  • Stefano Bernardi,
  • Margherita Sciarrotta,
  • Chiara Gatti,
  • Anna Nabacino,
  • Giulia Guaragna,
  • Lorenzo Acerbis,
  • Alice Beschi,
  • Benedetta Zuaboni,
  • Silvia Ramorino,
  • Luca Stella,
  • Claudia Capelli,
  • Rachele Antognoli,
  • Filippo Niccolai,
  • Valeria Calsolaro,
  • Lorenzo Vannucci,
  • Katia Nardi,
  • Arianna Tinagli,
  • Elena Carlino,
  • Noemi Pardini,
  • Alessandro Mengozzi,
  • Luca Soraci,
  • Mara Volpentesta,
  • Annalisa Cozza,
  • Marco Toto,
  • Anna Passarelli,
  • Ramona Caloiero,
  • Lucia Muglia,
  • Carmela Guzzo,
  • Cinzia Marinaro,
  • Laura Filice,
  • Elvira Clausi,
  • Giovanni Ruotolo,
  • Laura Greco,
  • Valentina Bambara,
  • Luana Mancuso,
  • Tania Falbo,
  • Maddalena Minelli,
  • Danny Bassis,
  • Massimo Barbieri,
  • Federico Ghidinelli,
  • Lucilla Guarneri,
  • Angelo Ferrari,
  • Davide Uberti,
  • Veronica Tanghetti,
  • Paola Tibaldi,
  • Lorella Lambertucci,
  • Giuseppe Dario Testa,
  • Maria Vittoria Silverii,
  • Francesca Tesi,
  • Luciano Gabbani,
  • Guido Ferratini,
  • Claudia Di Serio

摘要

Background

Hospitalisation frequently leads to hospital-acquired disability in older adults, with subsequent functional decline and loss of independence. However, the potential role of multidomain interventions (MDIs) integrating physical, nutritional and cognitive components, supported by digital technologies, remains largely unexplored in the acute care setting. OPTIMAge-IT therefore aims to evaluate the effect of a technology-supported MDI on motor function at hospital discharge and its feasibility in the post-discharge phase among frail older adults.

Methods

OPTIMAge-IT is an ongoing, pragmatic, multicentre, cluster-randomised controlled trial conducted in eight Italian Acute Geriatric Units. Adults aged ≥ 70 years admitted from the Emergency Department with mild-to-moderate frailty are enrolled consecutively and allocated by centre to usual care or a structured, multidisciplinary, technology-supported MDI. The intervention starts after clinical stabilisation and continues for 12 weeks post-discharge, supported by a tracker and a tablet. The MDI includes Vivifrail-based physical exercise, computerised cognitive training (BrainHQ), nutritional counselling, health education, medication review, and promotion of social engagement. The primary endpoint is change in Short Physical Performance Battery at hospital discharge. Secondary endpoints include feasibility of the intervention and its home continuation (adherence, usability and retention), as well as the effect of the MDI on in-hospital and post-discharge outcomes. Follow-up assessments are performed at 3 and 6 months in the intervention arm and at 6 months in the control arm; blood biomarkers are collected at discharge and at 6 months.

Discussion

OPTIMAge-IT will provide evidence on the feasibility and clinical value of a technology-supported MDI to prevent hospital-acquired disability and promote functional status in frail older adults. Findings may inform the development of scalable, person-centred post-hospital care models.

Trial registration

NCT06611228 (https://clinicaltrials.gov/study/NCT06611228; 2025–01-08).