2/2 PROmote weight loss in obese PAD patients to preVEnt mobility loss: The PROVE Trial--DCC

2/2 促进肥胖 PAD 患者减轻体重以防止活动能力丧失：PROVE 试验 - DCC

• 批准号: 10249064
• 负责人: WALTER T AMBROSIUS
• 金额: $ 9.72万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-10 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10249064
• 关键词: Adherence; Biometry; Body Weight decreased; Body mass index; Cardiovascular Diseases; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Collaborations; Collection; Communication; Complement; Conduct Clinical Trials; Consensus; Country; Data; Data Analyses; Data Coordinating Center; Data Management Resources; Database Management Systems; Databases; Development; Diabetes Mellitus; Elderly; Ensure; Environment; Evaluation; Exercise; Funding; Grant; Health; Human Resources; Inflammation; International; Internet; Intervention; Intervention Trial; Lead; Magnetic Resonance Imaging; Maintenance; Manuals; Manuscripts; Master' s Degree; Measurement; Methodology; Methods; Minnesota; Modeling; Monitor; Multicenter Studies; Multicenter Trials; Muscle; Obesity; Online Systems; Outcome; Outcome Study; Overweight; Participant; Patients; Peripheral arterial disease; Pharmaceutical Preparations; Physical activity; Procedures; Process; Productivity; Protocols documentation; Publications; Quality Control; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recording of previous events; Reporting; Research Design; Research Personnel; SF-12; Safety; Security; Site; Site Visit; Standardization; Stress; System; Talents; Technology; Training; United States National Institutes of Health; Vent; Visit; Walking; acronyms; adjudication; blood pressure intervention; cardiovascular risk factor; data management; electronic data; epidemiology study; exercise intervention; experience; follow-up; forest; innovation; intervention program; lifestyle intervention; medical schools; member; obese person; operation; participant safety; prevent; primary outcome; protocol development; quality assurance; recruit; secondary outcome; sound; standard of care; success; tool; website development

The PROVE Trial DCC Project Summary This U24 application from the Wake Forest School of Medicine (WFSM) describes plans by experienced inves- tigators and staff to serve as the Data Coordinating Center (DCC) for the PROmote weight loss in obese PAD patients to preVEnt mobility Loss: The PROVE Trial (PROVE), a N=212 trial. We will build on our successes in dozens of large, long-term trials and epidemiologic studies. Our DCC experience will help ensure success in the implementation of the PROVE Trial by overseeing all data related aspects of the trial. We have a single specific aim: to provide project coordination, administration, data management, and biostatistical support for the PROVE Trial. We will accomplish this aim by facilitating and guiding the protocol development process, by providing scientifically sound study design, excellent operational and analytical methodology, a dedicated focus on recruitment, high quality follow-up and fidelity to the intervention, monitoring safety and working with the DSMB to ensure participant safety and careful study management, working with the CCC to monitor field cen- ters (i.e., Northwestern, Minnesota, and Tulane), and by leading development and maintenance of the protocols, manual of procedures (MOP), forms and other study documents. We believe that PROVE Trial will have nearly all the complexities of large multi-center studies, particularly for the DCC in standardization across sites. We have several strengths: (1) a team whose members are experts in the coordination of multi-center trials, including several that are ongoing, (2) experience with cardiovascular disease (CVD) trials including the current SPRINT trial, (3) experience with exercise and weight loss trials working with the intervention proposed in the PROVE trial, (4) specific project management expertise, (5) a history of efficient and effective communication with field centers, the executive committee, and the project office, and (6) success working with Dr. McDermott (of the CCC) on two prior studies (LIFE and ENRGISE). WFSM views clinical trial conduct and coordination as a scientific undertaking, which advances through con- tinuous evaluation and innovation. While web-based randomized controlled trials (RCTs) have been conducted for almost two decades, we will continue to develop new and innovative strategies for integrating web-based technology into daily trial activities and incorporating other methods of electronic data capture into trial man- agement. We coordinated ACCORD, which was the first large-scale RCT coordinated primarily over the web. The ACCORD system has evolved into the Database for Efficient Administration of Clinical trial OperatioNs (DEACON) system for web-based trial management which we use for all of our studies. We are constantly in- venting and evaluating new features to add to the DEACON framework. The highly experienced and talented team at WFSM will create a state-of-the-art DCC for the PROVE trial using proven (pun intended) coordinating center models. Personnel will be available from day 1 and have long- standing working relationships across multiple NIH-funded studies.

PROVE试验DCC项目总结 这个来自维克森林医学院（WFSM）的U24应用程序描述了经验丰富的投资者的计划， 作为数据协调中心（DCC），促进肥胖PAD患者的体重减轻 PROVE试验（PROVE），一项N=212的试验。我们将在成功的基础上再接再厉 在几十个大型的长期试验和流行病学研究中。我们的DCC经验将有助于确保成功 通过监督试验的所有数据相关方面来实施PROVE试验。我们有一个 具体目标：提供项目协调、行政管理、数据管理和生物统计支持， 证明审判。我们将通过促进和指导协议制定过程来实现这一目标， 提供科学合理的研究设计，卓越的操作和分析方法，专注于 关于招募、高质量的后续行动和干预的可靠性、监测安全性以及与 DSMB应确保受试者安全和仔细的研究管理，与CCC合作监测现场中心， TERS（即，西北大学、明尼苏达大学和杜兰大学），并通过领导协议的开发和维护， 程序手册（MOP）、表格和其他研究文件。我们相信，证明审判将有近 大型多中心研究的所有复杂性，特别是DCC在跨中心标准化方面。 我们有几个优势：（1）团队成员是多中心试验协调方面的专家， 包括几个正在进行的，（2）心血管疾病（CVD）试验的经验，包括目前的 SPRINT试验，（3）运动和减肥试验的经验与建议的干预工作， 证明试验，（4）特定的项目管理专业知识，（5）高效且有效的沟通历史 与外地中心，执行委员会和项目办公室，（6）与麦克德莫特博士成功合作 (of CCC）的两项先前研究（LIFE和ENRGISE）。 WFSM将临床试验的实施和协调视为一项科学事业，通过以下方式推进： 持续评价与创新。虽然已经进行了基于网络的随机对照试验（RCT）， 近二十年来，我们将继续开发新的创新策略来整合基于网络的 技术纳入日常审判活动，并将其他电子数据采集方法纳入审判方式- - 是的我们协调了雅阁，这是第一个主要通过网络协调的大规模RCT。 雅阁系统已发展成为有效管理临床试验操作的数据库 （DEACON）系统用于基于网络的试验管理，我们将其用于所有研究。我们一直在- 通风和评估新功能添加到DEACON框架。 WFSM经验丰富、才华横溢的团队将为PROVE试验创建最先进的DCC 使用经过验证的（双关语）协调中心模型。工作人员将从第一天开始提供服务，并有很长的时间- 在多个NIH资助的研究中建立长期的工作关系。