Geriatrics Unit, Department of Geriatric Care, Neurology and Rehabilitation, E.O. Galliera Hospital, Genoa, Italy.
Department of Interdisciplinary Medicine, University of Bari "Aldo Moro", Bari, Italy.
Trials. 2024 Sep 13;25(1):611. doi: 10.1186/s13063-024-08413-1.
Multicomponent interventions based on a comprehensive geriatric assessment (CGA) could promote active aging and improve health status in older people with Noncommunicable Chronic Diseases (NCDs), but conflicting evidences are available.
To evaluate the efficacy of a CGA-based multicomponent personalized preventive program (PPP) in reducing unplanned hospitalization rates during 12-month follow-up in community-dwelling older people with NCDs.
In this randomized clinical trial (RCT), 1216 older adults recruited by 33 general practitioners (GPs) will be randomly allocated to intervention group (IG) or usual care control group (CG). The IG will receive a multicomponent PPP developed on the findings of the CGA-based Multidimensional Prognostic Index short-form (Brief-MPI), including structured interventions to improve functional, physical, cognitive, and nutritional status, to monitor NCDs and vaccinations, and to prevent social isolation. Participants in the CG will receive usual care. Brief-MPI, resilience, and health-related quality of life will be assessed after 6 and 12 months. Moreover, saliva samples will be collected at baseline in IG to measure biomarkers of oxidative stress, inflammatory cytokines, and oral microbiome.
The CGA-based PPP might reduce unplanned hospitalization rates and potentially institutionalization rates, emergency department (ED) and unplanned GP visits, and mortality. Further outcomes explored in the IG will be the adherence to PPP, resilience, health-related quality of life, and multidimensional frailty as assessed by the Brief-MPI.
Results will suggest whether the CGA-based multicomponent PPP is able to improve specific outcomes in a primary care setting.
ClinicalTrials.gov; identifier: NCT06224556 ; Registered January 25, 2024.
基于综合老年评估（CGA）的多组分干预措施可以促进老年人的积极老龄化并改善其患有非传染性慢性病（NCD）的健康状况，但现有证据相互矛盾。
评估基于 CGA 的多组分个性化预防方案（PPP）在减少 12 个月随访期间患有 NCD 的社区居住老年人非计划性住院率的效果。
在这项随机临床试验（RCT）中，33 名全科医生（GP）招募的 1216 名老年人将被随机分配到干预组（IG）或常规护理对照组（CG）。IG 将接受基于 CGA 的多维预后指数简表（Brief-MPI）发现制定的多组分 PPP，包括改善功能、身体、认知和营养状况的结构化干预措施，监测 NCD 和疫苗接种情况，并预防社会隔离。CG 中的参与者将接受常规护理。在 6 个月和 12 个月后将评估 Brief-MPI、韧性和与健康相关的生活质量。此外，IG 中的基线将收集唾液样本以测量氧化应激、炎症细胞因子和口腔微生物组的生物标志物。
基于 CGA 的 PPP 可能会降低非计划性住院率和潜在的住院率、急诊部（ED）和非计划性 GP 就诊率以及死亡率。在 IG 中进一步探索的结果将是 PPP 的依从性、韧性、与健康相关的生活质量以及通过 Brief-MPI 评估的多维虚弱程度。
结果将表明基于 CGA 的多组分 PPP 是否能够改善初级保健环境中的特定结果。
ClinicalTrials.gov；标识符：NCT06224556；注册于 2024 年 1 月 25 日。
