Evaluation of Novel Technologies to Improve Clinical Management of Celiac Disease

改善乳糜泻临床管理的新技术评价

基本信息

批准号：
10482373
负责人：
Benjamin Lebwohl
金额：
$ 35.84万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-07 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10482373
关键词：
Address Adherence Adoption Adult Affect Anemia Antibodies Anxiety Autoantibodies Awareness Behavioral Budgets COVID-19 pandemic Celiac Disease Chemistry Clinical Clinical Management Clinical Protocols Clinical Trials Communication Complement Consumption Cost Analysis Country Detection Development Diagnosis Dietitian Digestive System Disorders Disease Management Eating Behavior Effectiveness Evaluation Fatigue Food Funding Future Gastroenterology Gliadin Gluten Gluten-free diet Health Professional Height Histology Home Human Resources Illinois Immune System Diseases Immunoglobulin A Immunoglobulin G Incidence Individual Infertility Infrastructure Institutes Intervention Link Lymphocyte Count Malignant Neoplasms Manuals Massachusetts Measures Mediator of activation protein Mental Depression Methodology Monitor Morbidity - disease rate Mucous Membrane New York Newly Diagnosed Osteoporosis Outcome Outcome Study Participant Pathway interactions Patients Peptides Performance Persons Physicians Pisum sativum Population Principal Investigator Procedures Protocols documentation Quality of life Randomized Randomized Controlled Trials Recommendation Recovery Regimen Research Design Role Sample Size Serology Seroprevalences Serum Symptoms Technology Telemedicine Tennessee Testing Time TimeLine Tissue Transglutaminase Antibodies Training United States Urine Videoconferencing Villus Work acceptability and feasibility base clinical development cost cost effectiveness data handling dietary dietary adherence effectiveness evaluation effectiveness testing follow-up gastrointestinal symptom immunogenic improved intraepithelial meetings mortality new technology novel operation organizational structure pandemic disease portability primary endpoint primary outcome psychologic rapid testing recruit secondary outcome sensor sound standard of care stool sample tool validation studies

项目摘要

PROJECT SUMMARY The proposed project addresses the need for a rigorous trial to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in adults. Celiac disease affects about 1% of the United States (U.S.) population and seroprevalence has increased up to 5-fold in the U.S. since the 1950’s with diagnosis rates continuing to rise. Morbidity can be severe and includes anemia, infertility, osteoporosis, and malignancies, which can increase all-cause mortality. The only proven therapy is a strict gluten-free diet, the management of which can be extremely challenging and has been linked to diminished quality of life, including anxiety, depression, and fatigue. Despite the recommendation to see a dietitian regularly, many with celiac disease do not see one at all or have only a single session immediately post-diagnosis. The COVID-19 pandemic has catalyzed the rapid adoption of telemedicine in gastroenterology and can facilitate communication between patient and dietitian by eliminating the need to arrange face-to-face meetings at celiac disease centers, which may be at great distance. Self-monitoring with new technologies for gluten detection in food (e.g., portable gluten sensors) and urine (e.g., gluten immunogenic peptide kits) can facilitate greater individual awareness of gluten exposures, are commercially available to the public, and have been shown to be valid and reliable. Physicians and dietitians are being asked if these technologies should be used, and our preliminary studies have demonstrated acceptability and feasibility, but their impact on clinical outcomes such as mucosal recovery and symptoms has not been established. The proposed U34 project will prepare for a multi-center (New York, Massachusetts, Illinois, Tennessee) randomized controlled trial (M-RCT) to assess the effectiveness and document costs of gluten detection technologies as an adjunct to telemedicine on behavioral and clinical outcomes among newly diagnosed patients with celiac disease. Participants will be randomized to receive either 1) standard of care (i.e. a one-time in-person dietitian session plus continuous telemedicine dietitian follow-up; or 2) standard of care + gluten detection technologies. This would be the first large-scale clinical trial to test the effect of self-monitoring using gluten detection technology in the management of celiac disease. The primary outcome will be mucosal recovery 12-months post-randomization. Secondary outcomes include change in gastrointestinal symptoms, diet adherence, quality of life (including anxiety and depression), eating behaviors, intraepithelial lymphocyte counts on histology, and celiac disease serology, all assessed at baseline and again at 12-months post-randomization. The proposed project will develop a U01 proposal for the M-RCT which will include a Clinical Protocol, Manual of Procedures, and detailed timeline and budget that documents study design and measures, training and protocol implementation, data handling, and dissemination of findings. The significance of this U34 work is to assure a M-RCT that is methodologically sound and ready to implement. If successful, the proposed future U01 intervention will improve mucosal recovery and quality of life, promote a shift in current practice of celiac disease management toward long-term monitoring, and represent a significant step toward reducing the severe physical and psychological consequences of celiac disease.

项目摘要拟议的项目解决了进行严格试验以测试新面筋检测有效性的需求技术作为远程医疗管理成人腹腔疾病的辅助手段。乳糜泻影响约1％自1950年代以来，美国（美国）人口和血清阳性增长了5倍随着诊断率继续上升。发病率可能很严重，包括贫血，不育，骨质疏松症，和恶性肿瘤，可以增加全因死亡率。唯一经过验证的疗法是严格的无麸质饮食，管理的管理可能会受到极大的挑战，并且与生活质量下降有关，包括焦虑，抑郁和疲劳。尽管建议定期去看营养师，但许多人都有乳糜泻疾病根本看不到一种或仅在诊断后立即进行一次一次。 19009年大流行催化远程医疗在胃肠病学中的迅速采用，并可以促进通过消除需要在腹腔疾病中心安排面对面会议的需要，患者和营养师可能处于很大的距离。使用新技术进行食物麸质检测的自我监控（例如，便携式面筋传感器）和尿液（例如，麸质免疫原性肽试剂盒）可以促进对麸质的更高意识曝光，可向公众提供市售，已被证明是有效且可靠的。医师询问营养师是否应该使用这些技术，我们的初步研究具有可接受性和可行性，但它们对粘膜恢复和临床结果的影响尚未确定症状。拟议的U34项目将为多中心做准备（纽约，田纳西州伊利诺伊州马萨诸塞州）随机对照试验（M-RCT）评估有效性和麸质检测技术的文件成本作为远程医疗的行为和临床的辅助新诊断的乳糜泻患者的结果。参与者将被随机接收 1）护理标准（即一次亲身营养师会议以及连续的远程医疗营养师随访；或2）护理标准 +面筋检测技术。这将是第一个测试的大规模临床试验使用面筋检测技术在乳糜泻的管理中进行自我监控的影响。主要结果将是随机化后12个月的粘膜恢复。次要结果包括更改胃肠道症状，饮食依从性，生活质量（包括焦虑和抑郁），饮食行为，上皮内淋巴细胞对组织学和腹腔疾病血清学的计数，所有这些都在基线时进行了评估在随机后12个月。拟议的项目将针对M-RCT制定U01提案包括临床协议，手册以及详细的时间表和预算，记录了研究设计以及调查结果的措施，培训和协议实施，数据处理和传播。这这项U34工作的意义是确保在方法上是合理并准备实施的M-RCT。如果成功，拟议的未来U01干预将改善粘膜恢复和生活质量，促进当前乳糜泻管理实践向长期监测转移，并代表着重要的迈向减少腹腔疾病的严重身体和心理后果的一步。