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.

项目摘要 1型糖尿病（T1D）治疗依从性很复杂，涉及葡萄糖监测，计数碳水化合物和通过注射或胰岛素泵的强化胰岛素递送，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治疗依从性是具有挑战性的，尤其是在青春期，这可能导致次优血糖水平，从而严重损害健康，并且在某些情况下，导致过早死亡。对于患有T1D的青少年的几种干预措施，但没有专注于依从性障碍。糖尿病依从性量表的障碍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。这些坚持障碍与不遵守性，高血糖水平和较低生活质量显着相关；但是，没有干预措施解决研究或临床实践中的这两个障碍。总体目标这项研究是利用依从性障碍的患者报告来确定将指导的干预目标将新型量身定制干预措施整合到临床护理中，以提高粘附，血糖水平和质量生活。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问卷，包括糖尿病依从量表的障碍和pedsql-diabetes模块在两个大型T1D中心进行护理。其次，我们现有的干预措施，癫痫旅程将被修改为糖尿病旅行。该干预措施包括解决压力和执行功能的移动健康模块（即伴随的远程医疗会议与治疗师。我们将使用专家反馈来修改模块，然后进行执行与10名具有T1D的青少年进行可用性测试，以确保模块易于导航，参与和与T1D的青少年有关。第三，我们将对糖尿病旅程进行试点临床试验。我们的目标是评估糖尿病之旅如何有助于改善压力/倦怠和时间压力/计划（例如，执行功能障碍）在256名具有T1D的青少年以及青少年是否认为糖尿病之旅是否有帮助并且可以接受。在常规T1D诊所访问期间经历较高依从性障碍的青少年将随机分配到：1）糖尿病旅程或2）增强的护理标准（即，讲义和4个电话。认证的糖尿病教育者）。这两种干预措施将针对每个青少年报告的障碍量身定制。我们还将检查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，执行功能和困扰如何影响依从性未来研究的障碍和行为。如果我们的研究成功，我们将扩大糖尿病之旅额外的依从性障碍并修改其他年龄段，从而导致较大的多站点T1D临床研究。