Evaluating Affective and Unified Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control

评估减少糖尿病困扰和改善血糖控制的情感和统一行为方法

基本信息

批准号：
10381712
负责人：
LAWRENCE FISHER
金额：
$ 62.87万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
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/10381712
关键词：
Abate Address Adult Affective Age Area Behavior Behavior Control Behavioral Caring Characteristics Chronic Chronic Disease Clinical Clinical Research Cognition Cognitive Development Diabetes Mellitus Disease Management Distress Education Effectiveness of Interventions Emotional Emotions Evidence based intervention Floor Future Gender Glycosylated hemoglobin A Goals Hypoglycemia Individual Insulin-Dependent Diabetes Mellitus Intervention Intervention Studies Knowledge Link Literature Major Depressive Disorder Mediating Motivation Participant Pathway interactions Patients Population Problem Solving Progressive Disease Quality of life Research Design Sampling Studies Self Care Self Management Side Source Stress Testing Theoretical Effectiveness Time Work arm base cost estimate demographics diabetes distress diabetes education effective intervention emotion regulation future implementation glycemic control improved intervention cost intervention effect prevent primary outcome programs relative effectiveness secondary outcome systematic review three-arm clinical trial

项目摘要

PROJECT SUMMARY/ABSTRACT Diabetes distress (DD) refers to the often hidden emotional burdens, stresses, and worries that result from managing a demanding, progressive, and chronic disease like type 1 diabetes (T1D). DD is highly prevalent, with approximately 42% of T1D adults manifesting elevated DD; is distinct from clinical depression; tends to be chronic, rather than episodic; and has been significantly associated with poor glycemic control and problematic self-care behavior. Systematic reviews suggest the development of effective interventions for DD have been impeded by: the majority of interventions not targeting DD directly, instead delivering various forms of diabetes education and disease-management, few studies being grounded in a theoretical framework that drives an intervention strategy; study designs that rarely allow for direct comparison of different approaches to reduce DD; relatively few studies focused on T1D, and no study to date that has explored different approaches to DD reduction in ways that directly maximize improvements in glycemic control. To address these problems we propose a 3-arm clinical trial with T1D adults that uses theoretically supported, evidenced-based interventions to test the added value of a program that targets DD directly through emotion regulation strategies (TunedIn) and a unified DD and disease management intervention (FixIt) to reduce DD and improve glycemic control, relative to a traditional education/disease management intervention (StreamLine). The primary outcome is HbA1c. We will explore mediating pathways linking changes in DD with changes in HbA1c over time. The effect of selective moderating variables on intervention effectiveness will be assessed. Intervention costs and stakeholder input will inform dissemination and future program implementation.

项目概要/摘要糖尿病困扰 (DD) 是指由于糖尿病引起的经常隐藏的情绪负担、压力和担忧治疗 1 型糖尿病 (T1D) 等要求较高的、进行性慢性疾病。 DD 非常普遍，大约 42% 的 T1D 成人表现出 DD 升高；与临床抑郁症不同；往往是慢性的，而不是间歇性的；并与血糖控制不佳和问题显着相关自我照顾行为。系统评价表明，针对 DD 的有效干预措施的制定已取得进展阻碍因素：大多数干预措施并不直接针对 DD，而是导致各种形式的糖尿病教育和疾病管理方面，很少有研究以推动疾病管理的理论框架为基础。干预策略；研究设计很少允许直接比较不同的方法来减少 DD；关注 T1D 的研究相对较少，迄今为止还没有研究探索治疗 DD 的不同方法减少直接最大限度地改善血糖控制的方式。为了解决这些问题我们提出一项针对 T1D 成人的 3 组临床试验，该试验使用理论支持的、基于证据的干预措施测试通过情绪调节策略直接针对 DD 的计划的附加值 (TunedIn) 以及统一的 DD 和疾病管理干预措施 (FixIt)，以减少 DD 并改善血糖控制，相对于传统的教育/疾病管理干预（StreamLine）。主要结果是糖化血红蛋白 (HbA1c)。我们将探索随时间推移将 DD 变化与 HbA1c 变化联系起来的中介途径。这将评估选择性调节变量对干预效果的影响。干预成本和利益相关者的意见将为传播和未来计划的实施提供信息。