An Atlanta TrialNet Center: Building a Pathway to 70 Clinical Trial Subjects per Year

亚特兰大 TrialNet 中心：建立每年 70 名临床试验受试者的途径

基本信息

批准号：
8977670
负责人：
Andrew B Muir
金额：
$ 32.34万
依托单位：
EMORY UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-07-20 至 2018-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8977670
关键词：
Address Adult Affect American Area Autoantibodies Biomedical Engineering Car Phone Caring Cessation of life Child Childhood Cities Clinic Clinical Clinical Sciences Clinical Trials Collaborations Communication Custom Diabetes Mellitus Diabetes prevention Doctor of Philosophy Endocrinologist Endocrinology Enrollment Ensure Environment Event Exhibits Faculty Family Goals Grant Growth Health Healthcare Hour Institutes Insulin-Dependent Diabetes Mellitus Intervention Interview Kidney Diseases Laboratories Leadership Learning Marketing Methods Microvascular Dysfunction Mission Modeling Monitor Monkeys Motivation OGTT Onset of illness Participant Pathway interactions Patients Phase Physicians&apos Offices Population Prevention trial Process Productivity Psychologist Questionnaires Recording of previous events Recruitment Activity Relative (related person)Reporting Research Personnel Resources Risk Screening Result Series Services Sickle Cell Anemia Site Students Surveys Technology Teenagers Training Translational Research Universities Visit base design design and construction eligible participant experience high risk improved innovation insulin dependent diabetes mellitus onset interest metropolitan mortality motivational enhancement therapy novel outreach pediatric department pediatric patients prevent programs public health relevance screening therapy design web site

项目摘要

DESCRIPTION (provided by applicant): The mission of a TrialNet Center is to engage subjects at risk for type 1 diabetes (T1D) in clinical trials to prevent or delay the onset of the disease. TrialNet's importance is emphasized by persistently high rates of nephropathy among people with T1D, despite declines in other microvascular complications and a recently reported increase in mortality among teens with T1D. With a population of 5.5 million, some 20,000 Atlantans have T1D. Thus, there is enormous opportunity to increase number of local TrialNet participants. This Center application proposes a 4-year plan to triple the current rate of TrialNet enrollment by the Emory University team and to improve the retention rate of autoantibody-positive subjects from 67 to 85 percent. These goals will be attained by expanding our recruiting outreach that has focused so far on the Emory pediatric diabetes clinic. We now propose to span all of Atlanta's pediatric endocrinology offices and selected, productive adult endocrinology practices. A history of collaboration among Atlanta's pediatric endocrinologists and the convergence of virtually all of the area's pediatric T1D patients on Children's Healthcare of Atlanta (CHOA) assure us access to virtually every family with an affected child. We further propose a series of office-based recruiting methods to introduce TrialNet to adult endocrinology offices in Atlanta. A greeter will make initial contact with patients visiting their endocrinologis for routine T1D care and facilitate methods to identify potentially interested relatives who will atten a screening event or enter TrialNet through a local laboratory. A custom mobile phone application will be designed to ease the patient's outreach to their family while keeping communications confidential. The greeter will rotate through the offices with a focus point being an off-hours screening event to be held at their physicians office in the coming month. These multi-media events will include educational exhibits/activities constructed by senior biomedical engineering students attending the Georgia Institute of Technology. The events and other TrialNet activities will be supported by a website hosted by Emory Pediatric Endocrinology and CHOA. Retention rates will be improved by implementing a motivational interviewing intervention. The intervention will be launched by completion of a 12-item questionnaire on Survey Monkey both before and after screening results are reported to subjects. It will determine each subject's motivation for participating in TrialNet and explore potential barriers to further activity should they turn out to be autoantibody-positive. After receiving a report of a positive autoantibody, a pediatric psychologist with expertise in motivational interviewing will us the survey information to guide an interview aimed at reducing barriers and encouraging retention in TrialNet. A TrialNet Center at Emory University will bring real growth to TrialNet without impinging on the activities of existing TrialNet Centers. It offers a highly trained staff, collaborations with innovative faculty and private practitioners, the ingenuity of bioengineers at Georgia Tech, and support from the many sites of the Atlanta Clinical and Translational Science Institute.

描述（由申请人提供）：TrialNet 中心的使命是让有 1 型糖尿病 (T1D) 风险的受试者参与临床试验，以预防或延缓该疾病的发作，这一点因肾病发病率持续居高而得到强调。尽管其他微血管并发症有所减少，而且最近报道 1 型糖尿病青少年死亡率有所上升，但亚特兰大人口有 550 万，约有 20,000 人患有 1 型糖尿病。 T1D。因此，增加本地 TrialNet 参与者数量的机会巨大。该中心申请提出了一项将 TrialNet 当前比率提高三倍的计划。埃默里大学团队的入学率并将自身抗体阳性受试者的保留率从 67% 提高到 85%，这些目标将通过扩大我们目前专注于埃默里儿科糖尿病诊所的招募范围来实现。亚特兰大的所有儿科内分泌办公室和选定的、富有成效的成人内分泌实践亚特兰大儿科内分泌学家之间的合作历史以及该地区几乎所有儿科 T1D 患者在儿童方面的融合。亚特兰大医疗保健 (CHOA) 确保我们能够接触到几乎每个有受影响儿童的家庭。我们进一步提出了一系列基于办公室的招募方法，将 TrialNet 介绍给亚特兰大的成人内分泌科办公室，接待员将与就诊内分泌科医生的患者进行初步接触。常规 T1D 护理，并促进确定可能感兴趣的亲属参加筛查活动或通过当地实验室进入 TrialNet 的方法，以方便患者与家人联系，同时保持通信保密。旋转这些多媒体活动将包括由佐治亚理工学院高年级生物医学工程学生举办的教育展览/活动。这些活动和其他 TrialNet 活动将由埃默里儿科内分泌学和 CHOA 主办的网站提供支持，并通过实施动机性访谈干预措施来提高保留率。干预措施将通过完成包含 12 项的调查猴子问卷来启动。在向受试者报告筛选结果之前和之后，它将确定每个受试者参与 TrialNet 的动机并探索潜在的障碍。如果他们的自身抗体呈阳性，则应采取进一步的行动在收到自身抗体呈阳性的报告后，具有动机访谈专业知识的儿科心理学家将利用调查信息来指导访谈，旨在减少障碍并鼓励他们保留在 TrialNet 中。埃默里大学中心将为 TrialNet 带来真正的增长，而不会影响现有 TrialNet 中心的活动。它提供训练有素的员工，与创新教师和私人从业者的合作、佐治亚理工学院生物工程师的独创性以及来自亚特兰大临床和转化科学研究所许多地点的支持。