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

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).