Leader: Giuseppe Bellelli (UNIMIB); Other collaborator(s): All Spoke 8 Partners and possible participation of researchers from other Spoke
WP2 will implement and assess multidomain interventions in 288 older adults with mild-moderate frailty admitted to 8 acute wards to prevent hospitalization-acquired disability. Four wards will receive interventions, 4 will be controls. Follow-up will be at 3- and 6- month post-discharge. The study will also evaluate technology-supported interventions for promoting continuity of care, including physical, nutritional, cognitive, and psychological components, health education, and polypharmacy review. Technology will include wearables and smartwatches. Activities will include recruitment, intervention development, data collection, analysis, and dissemination. Overall, WP2 aims to inform health policymakers and citizen about the effective strategies for preventing decline and explore post-hospitalization care innovations.
Brief description of the activities and of the intermediate results
WP2 has achieved significant milestones in the development and implementation of the OPTIMAge-IT study protocol.
Main policy, industrial and scientific implications
To address the expected impact of biomarkers on efficacy of multi-intervention approach . These results will be useful in eventual ongoing modfification of clinical trials
Brief description of the activities and intermediate results
The project has advanced significantly since the last update:
Hiring of Professionals for Multi-Component Interventions:
A dedicated professional team has been hired to oversee and implement the multi-component interventions, marking a key step in operationalizing the study's core objectives.
Acquisition of Required Technologies:
The necessary technologies, including tablets and smartwatches, have been acquired and are ready for deployment across study sites, ensuring real-time data collection and monitoring capabilities.
IRB Approval:
Almost all participating centers have now obtained IRB (Institutional Review Board) approval, bringing us closer to full-scale implementation of the study.
Harmonization and Training:
We are currently in the middle of the harmonization phase, standardizing protocols and procedures across centers. Simultaneously, training sessions are being conducted to ensure all staff are fully prepared for the study's requirements.
Study Registration:
The OPTIMAge-IT study has officially been registered on ClinicalTrials.gov (NCT06611228), adding further credibility to the project and ensuring transparency in reporting.
Timeline for Enrollment:
The enrollment of participants is scheduled to begin by 15 November 2024, marking the start of the clinical phase of the project.
Main policy, industrial, and scientific implications
The integration of technology (tablets and smartwatches) into the intervention framework will enhance the precision of data collection and participant monitoring. The completion of harmonization and training will further solidify the study's methodological rigor, ensuring consistency across all sites. These advancements are crucial steps in paving the way for scalable, technology-driven interventions in elderly care.
Next Steps
Brief description of the activities and intermediate results
Participant Enrollment: The recruitment phase commenced in the Monza Hospital on 2nd Dicember 2024. Initial engagement has been promising, and efforts are ongoing to ensure continued adherence to study protocols.
Multi-Component Intervention Implementation: The multi-component interventions are now fully operational in most centers. The professional team overseeing these interventions is actively engaged in executing structured protocols to optimize patient outcomes.
Technology Deployment: The integration of tablets and smartwatches into daily monitoring is in full effect. These technologies are facilitating real-time data collection, ensuring high-quality and continuous monitoring of participants.
Completion of IRB Approvals: 5 out of 6 participating centers have now received full Institutional Review Board (IRB) approval, allowing for smooth and compliant execution of study activities across sites.
Harmonization and Training Completion: The harmonization phase has been successfully completed, with all sites adhering to standardized protocols. Training sessions for staff have been finalized, ensuring consistent execution of interventions and assessments.
Baseline Data Collection and Initial Analysis: Data collection is ongoing.
Brief description of the activities and intermediate results
Participant Enrollment:
All participating centers have now started recruitment. Despite initial delays, the enrollment process is active across all sites.
Multi-Component Interventions:
Interventions are ongoing in the intervention wards, and patients are actively participating in physical, nutritional, and cognitive activities.
Technology Use:
Tablets and smartwatches are being used effectively across sites for remote monitoring and engagement. Feedback from both patients and professionals is very positive regarding usability and relevance.
Follow-Up Visits:
The first 3-month follow-up assessments have started, with good participation rates observed. Data collection is proceeding as planned.
Scientific Dissemination:
The manuscript describing the overall design of the six WP (including WP2) is currently under peer review at Journal of Gerontology: Series A – Social Sciences.
Critical Issue:
A notable barrier to recruitment is the stringency of the frailty-based inclusion criteria. These criteria, while methodologically necessary, have limited the eligible patient pool. This reflects a broader issue in Italian geriatric wards, where the majority of patients tend to be severely frail and clinically complex, thus ineligible for this specific protocol.
Main policy, industrial, and scientific implications
The study confirms the feasibility and acceptability of technology-supported, multidomain interventions in real-world hospital settings.
The recruitment challenge highlights a mismatch between inclusion criteria and real-world patient populations, with implications for the generalizability of trials targeting older adults with "mild to moderate" frailty.
Next Steps
Ongoing recruitment monitoring:
Implement supportive strategies to facilitate patient enrollment while maintaining methodological rigor.
Continuation of follow-up assessments:
Proceed with 3- and 6-month evaluations, ensuring data completeness and patient retention.
Initial data analysis:
Begin preliminary analyses on baseline and early follow-up data to explore intervention effects.
Dissemination planning:
Prepare abstracts and communications to share early findings with the scientific community and health policymakers.