Diabetes Journey: From systematic screening to intervention

糖尿病之旅：从系统筛查到干预

基本信息

批准号：
10380129
负责人：
Kimberly Driscoll
金额：
$ 43.02万
依托单位：
CINCINNATI CHILDRENS HOSP MED CTR
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-04-01 至 2024-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10380129
关键词：
Academic Medical Centers Acute Address Adherence Adolescence Adolescent Affect Age American Appointment Behavior Biometry Blood Glucose Carbohydrates Caring Certification Cessation of life Childhood Clinic Clinic Visits Clinical Clinical Research Clinical Trials Complex Complications of Diabetes Mellitus Conflict (Psychology)Data Diabetes Mellitus Diabetic Ketoacidosis Distress Eating Effectiveness of Interventions Ensure Epilepsy Evaluation Executive Dysfunction Exercise Family Feedback Fright Future Glycosylated hemoglobin A Goals Health Hypoglycemia Individual Injections Insulin Insulin Infusion Systems Insulin-Dependent Diabetes Mellitus Intervention Kidney Failure Measurement Mediating Mediator Mental Depression Monitor Outcome Outcome Assessment Patient Outcomes Assessments Patients Pharmacology Population Problem Solving Psychologist Public Health Quality of life Questionnaires Randomized Recommendation Reporting Research Site Standardization Stress Systemic Therapy Technology Teenagers Telemedicine Telephone Testing Time Translating Videoconferencing Youth age group behavioral adherence burnout clinical care clinical practice depressive symptoms diabetes educator diabetes management efficacy trial executive function experience glucose monitor glycemic control health related quality of life improved improved outcome innovation mHealth member motivational enhancement therapy neglect novel premature pressure prevent primary outcome response routine care screening secondary outcome skills standard of care treatment adherence treatment group usability

项目摘要

Project Summary Type 1 diabetes (T1D) treatment adherence is complex and involves glucose monitoring, counting carbohydrates, and intensive insulin delivery via injections or insulin pump in response to food intake, exercise, and illness to achieve near-normal blood glucose levels. T1D treatment adherence is challenging, especially during adolescence, which can lead to suboptimal blood glucose levels that severely compromises health, and in some cases, leads to premature death. Several interventions for adolescents with T1D exist, but none have focused on adherence barriers. The Barriers to Diabetes Adherence scale assesses these important targets for tailored adherence interventions, including stress/burnout and time pressure/planning. These adherence barriers are significantly associated with non-adherence, higher glycemic levels, and lower quality of life; however, no interventions address these two barriers in research or clinical practice. The overall objective of this study is to use patient-report of adherence barriers to identify intervention targets that will guide the integration of a novel tailored intervention into clinical care to improve adherence, glycemic levels, and quality of life. There are four aims of our multi-site R01. First, we plan to reliably integrate patient-reported questionnaires, including the Barriers to Diabetes Adherence scale and PedsQL-Diabetes Module, into routine care in two, large T1D centers. Second, our existing intervention, Epilepsy Journey will be modified to Diabetes Journey. This intervention includes mobile health modules addressing stress and executive functioning (i.e., the skills needed to start and complete tasks, remember things, and be organized) with accompanying telemedicine sessions with a therapist. We will use expert feedback to modify the modules and then conduct usability testing with 10 adolescents with T1D to ensure the modules are easy to navigate, engaging, and relevant to teens with T1D. Third, we will conduct a pilot clinical trial of Diabetes Journey. Our goal is to evaluate how well Diabetes Journey helps to improve stress/burnout and time pressure/planning (e.g., executive dysfunction) in 256 adolescents with T1D and whether adolescents think Diabetes Journey is helpful and acceptable. Adolescents who experience elevated adherence barriers during routine T1D clinic visits will be randomized to: 1) Diabetes Journey or 2) enhanced standard of care (i.e., handouts and 4 phone calls from a certified diabetes educator). Both interventions will be tailored to each adolescent's reported barrier(s). We will also examine the impact of Diabetes Journey on adherence, glycemic control, and quality of life. Finally, we will examine how family conflict, depressive symptoms, executive functioning, and distress affect adherence barriers and behaviors for future studies. If our study is successful, we will expand Diabetes Journey to include additional adherence barriers and modify to other age groups, leading to larger multi-site T1D clinical studies.

项目概要 1 型糖尿病 (T1D) 治疗依从性很复杂，涉及血糖监测、计数碳水化合物，以及通过注射或胰岛素泵强化胰岛素输送，以响应食物摄入、运动、和疾病以达到接近正常的血糖水平。 T1D 治疗依从性具有挑战性，尤其是在青春期，这可能导致血糖水平不理想，严重损害健康，以及在某些情况下，会导致过早死亡。针对患有 T1D 的青少年有几种干预措施，但没有一个有效重点关注依从性障碍。糖尿病依从性障碍量表评估了这些重要目标量身定制的依从性干预措施，包括压力/倦怠和时间压力/计划。这些坚持障碍与不依从、较高的血糖水平和较低的生活质量显着相关；然而，没有任何干预措施可以解决研究或临床实践中的这两个障碍。总体目标本研究旨在利用患者报告的依从性障碍来确定干预目标，以指导将新颖的定制干预措施融入临床护理中，以提高依从性、血糖水平和质量的生活。我们的多站点 R01 有四个目标。首先，我们计划可靠地整合患者报告调查问卷，包括糖尿病依从性障碍量表和 PedsQL-糖尿病模块，纳入常规在两个大型 T1D 中心进行护理。第二，我们现有的干预措施，癫痫之旅将修改为糖尿病旅行。这种干预措施包括解决压力和执行功能的移动健康模块（即，开始和完成任务、记住事情和组织起来所需的技能）以及伴随的与治疗师进行远程医疗会议。我们将根据专家的反馈修改模块，然后进行对 10 名患有 T1D 的青少年进行可用性测试，以确保模块易于导航、吸引人并且易于使用与患有 T1D 的青少年相关。第三，我们将开展糖尿病之旅的试点临床试验。我们的目标是评估糖尿病之旅如何帮助改善压力/倦怠和时间压力/计划（例如， 256 名 T1D 青少年的执行功能障碍以及青少年是否认为糖尿病之旅有帮助并可以接受。在常规 T1D 诊所就诊期间经历较高依从性障碍的青少年将被随机分配到：1) 糖尿病之旅或 2) 增强的护理标准（即，讲义和 4 个电话）一名经过认证的糖尿病教育者）。这两种干预措施都将根据每个青少年报告的障碍进行定制。我们还将研究糖尿病之旅对依从性、血糖控制和生活质量的影响。最后，我们将研究家庭冲突、抑郁症状、执行功能和痛苦如何影响依从性未来学习的障碍和行为。如果我们的研究成功，我们将扩大糖尿病之旅以包括额外的依从性障碍并针对其他年龄组进行修改，从而导致更大规模的多中心 T1D 临床研究。