Pilot Studies Core

项目总结 缺乏针对痴呆症患者(PWD)及其照顾者的研究测试干预措施 世界各地的环境阻碍了卫生保健系统(HCS)充分照顾这种快速增长的疾病的能力 和高度脆弱的人群。嵌入HCS的实用临床试验(EPCT)可以解决这一问题 缺点。然而，ePCT是复杂的，需要特定的方法，熟练的调查人员，接近 与HCS的合作伙伴关系、强大的数据基础设施以及特殊的监管和道德考量。超过了 在过去的几年里，个别调查小组已经开始获得执行ePCT的经验。 在残疾人和他们的照顾者中。他们的经验加强了试点阶段是多么不可或缺的信息 成功地进行了全面的ePCT。国家老龄研究所(NIA)AD/ADRD HCS的试点核心 因此，研究合作实验室将征集并资助30多个试点ePCT，然后指导这些项目的所有方面 在他们的整个生命周期中学习。核心将1)创建一个稳健和透明的审查过程，2)提供 积极的技术援助，以增加资助试点的成功，3)促进发展 通过有组织的培训，研究人员的专业知识和跨项目的经验，以及4)促进 将试点测试的干预措施改编为精心设计的电子控制技术。最终，这将导致全面 电子通信技术，同时建设开展电子通信技术的调查员能力。Pilot Core将由Dr。 亚伯拉罕·布罗迪，博士，RN，FAAN，纽约大学护理与医学副教授 在痴呆症和ePCT方面有丰富经验的护士研究员，将与一名高度熟练的， 跨学科，执行委员会。Pilot Core将利用NIA的整体基础设施 AD/ADRD HCS合作实验室将实现：目标1：征集、严格审查、选择和资助将 导致未来全面开展以残疾患者及其照顾者为重点的ePCT；目标2：提供监测， 指导和资源，以确保严格、及时地完成试点里程碑，并有效分享 试点数据和结果；目标3：促进试点项目调查员在开展电子通信技术方面的专门知识 残疾人及其照顾者：1.将他们纳入AD/ADRD合作实验室的活动和工作 集团核心，2.提供对培训核心主导的结构化培训机会的访问，以及3.持有 3-5年级的年度科学会议，介绍和分享研究和经验；目标4：协助 试点项目，将已完成的试点项目转变为在残疾人和/或残疾人中成功资助的全面电子控制技术 他们的照顾者。影响：NIA AD/ADRD合作实验室试点核心将协助研究人员调查 可在为500多万残障人士及其照顾者提供服务的保健中心实施的实际干预措施。 这些试点将播种多个全面的ePCT，旨在改善 这些脆弱的人群。它还将促进试点项目领导人的专业知识和职业发展，增强 国家在未来很长一段时间内在有残疾的残疾人中开展ePCT的能力。

PROJECT SUMMARY The lack of research testing interventions targeting patients with dementia (PWD) and their caregivers in real- world settings hinders the ability of health care systems (HCS) to adequately care for this rapidly expanding and highly vulnerable population. Pragmatic clinical trials that are embedded in HCS (ePCTs) can address this shortcoming. However, ePCTs are complex, require specific methodologies, skilled investigators, close partnerships with HCS, robust data infrastructures, and special regulatory and ethical considerations. Over the past several years, individual teams of investigators have begun to acquire experience conducting ePCTs among PWD and their caregivers. Their experience has reinforced how indispensable a pilot phase is to inform the successful conduct of the full ePCT. The Pilot Core of the National Institute on Aging (NIA) AD/ADRD HCS Research Collaboratory will therefore solicit, and fund over 30 pilot ePCTs and then guide all aspects of these studies throughout their lifecycles. The Core will 1) create a robust and transparent review process, 2) provide active technical assistance to increase the success of funded pilots, 3) promote the development of investigator expertise and leverage experiences across projects through structured trainings, and 4) facilitate the adaptation of pilot tested interventions into well-designed ePCTs. Ultimately, this will lead to full-scale ePCTs, and simultaneously build investigator capacity to conduct ePCTs. The Pilot Core will be led by Dr. Abraham Brody, PhD, RN, FAAN, Associate Professor of Nursing and Medicine at New York University, a nurse researcher with significant experience in dementia and ePCTs, who will work with a highly skilled, interdisciplinary, Executive Committee. The Pilot Core will leverage the overall infrastructure of the NIA AD/ADRD HCS Collaboratory to achieve: Aim 1: Solicit, rigorously review, select, and fund projects that will lead to future full-scale ePCTs focused on PWD and their caregivers; Aim 2: Provide the monitoring, mentorship, and resources to ensure rigorous, timely completion of pilot milestones, and effective sharing of pilot data and results; Aim 3: Promote the expertise of pilot project investigators in conducting ePCTs with PWD and their caregivers by: 1. Integrating them into the activities of the AD/ADRD Collaboratory and Working Group Cores, 2. Providing access to structured training opportunities led by the Training Core, and 3. Holding an annual Scientific Conference in Years 3-5 to present and share research and experiences; Aim 4: Assist pilot projects to transform completed pilot projects into successfully funded full-scale ePCTs in PWD and/or their caregivers. IMPACT: The NIA AD/ADRD Collaboratory Pilot Core will assist researchers to investigate practical interventions that can be implemented in HCS that serve over 5 million PWD and their caregivers. These pilots will seed multiple full-scale ePCTs aimed at improving the quality of life and health outcomes of this vulnerable population. It will also foster the expertise and career growth of pilot project leaders, enhancing the nation’s capacity to conduct ePCTs among PWD with HCS well into the future.