National Clinical Research Center for Geriatrics, West China Hospital of Sichuan University, Chengdu, China.
The First Affiliated Hospital of Chengdu Medical College, Chengdu, China.
BMC Neurol. 2023 Sep 28;23(1):341. doi: 10.1186/s12883-023-03390-5.
Dementia is characterized by progressive neurodegeneration and therefore early intervention could have the best chance of preserving brain health. There are significant differences in health awareness, living customs, and daily behaviors among Chinese older adults compared to Europeans and Americans. Because the synergistic benefits of multidomain non-pharmacological interventions are consistent with the multifactorial pathogenicity of MCI, such interventions are more appealing, easier to adhere to, and more relevant to daily life than single-mode interventions. One of the aims of this study is to verify the effect of multidomain intervention strategies for MCI patients based on Chinese population characteristics, and the other is to establish a biobank and image database to investigate the pathogenesis and pathways of cognitive impairment.
Our study was designed as a national multicenter, community-based randomized controlled trial (RCT). Twelve medical institutions in ten Chinese cities will participate in our study from 2020 to 2024, and 1080 community residents aged 50 and above will be enrolled as participants. Each sub-center will be responsible for 90 participants (30 people per community) across three communities (non-contact control group, health education group, and multidomain intervention group). The community will be the basic unit of the present study, and all participants in each community will receive the same intervention/control measure. Three working groups are set up in each sub-center to manage the three communities independently to minimize interference at the implementation level between the groups. The multidomain intervention group will receive integrated interventions including exercise, nutrition, sleep, health education and mindfulness meditation. All data generated by the research will be analyzed and processed by statistical software (such as SPSS 21.0, Python 3.0, etc.), and part of the research data will be displayed in the form of graphs and tables.
In order to achieve a high-quality community intervention study, it is crucial to have a well-designed experimental protocol that follows rigorous scientific methodology. In addition, effective management of quality control measures and monitoring compliance throughout the study process are essential components. This study provides a detailed discussion of stakeholder compliance, research quality control, potential harm and mitigation, auditing, and future plans in order to better address research issues.
ChiCTR2000035012 (July 27, 2020).
痴呆症的特征是进行性神经退行性变，因此早期干预可能是保持大脑健康的最佳机会。与欧洲人和美国人相比，中国老年人在健康意识、生活习俗和日常行为方面存在显著差异。由于多领域非药物干预的协同益处与 MCI 的多因素发病机制一致，因此这些干预措施比单一模式干预更具吸引力、更容易坚持且更贴近日常生活。本研究的目的之一是基于中国人群特征验证多领域干预策略对 MCI 患者的效果，另一个目的是建立生物库和图像数据库，以研究认知障碍的发病机制和途径。
我们的研究设计为全国多中心、社区为基础的随机对照试验（RCT）。2020 年至 2024 年，来自十个中国城市的十二家医疗机构将参与我们的研究，将招募 1080 名 50 岁及以上的社区居民作为参与者。每个分中心将负责三个社区（非接触对照组、健康教育组和多领域干预组）的 90 名参与者（每个社区 30 人）。社区将是本研究的基本单位，每个社区的所有参与者将接受相同的干预/对照措施。在每个分中心设立三个工作组，分别管理三个社区，以最大限度地减少组间在实施层面的干扰。多领域干预组将接受包括运动、营养、睡眠、健康教育和正念冥想在内的综合干预措施。研究产生的所有数据将由统计软件（如 SPSS 21.0、Python 3.0 等）进行分析和处理，部分研究数据将以图表和表格的形式呈现。
为了实现高质量的社区干预研究，制定遵循严格科学方法的精心设计的实验方案至关重要。此外，在整个研究过程中有效管理质量控制措施和监测依从性也是重要组成部分。本研究详细讨论了利益相关者依从性、研究质量控制、潜在危害和缓解措施、审核以及未来计划，以更好地解决研究问题。
ChiCTR2000035012（2020 年 7 月 27 日）。
