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：
9904621
负责人：
LAWRENCE FISHER
金额：
$ 64.68万
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 2023-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9904621
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 Estrogen receptor positive 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 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.

项目摘要/摘要糖尿病困扰（DD）是指经常隐藏的情感负担，压力和担忧管理苛刻，进步和慢性疾病，例如1型糖尿病（T1D）。 DD非常普遍，大约42％的T1D成年人表现出DD升高；与临床抑郁症不同；倾向于慢性，而不是情节；并且与不良血糖控制和有问题有关自我保健行为。系统评价表明，开发了DD有效干预措施阻碍：大多数干预措施不直接针对DD，而是提供各种形式的糖尿病教育和疾病管理，很少有研究以驱动的理论框架为基础干预策略；研究设计很少可以直接比较不同的方法来减少 DD;相对较少的研究集中在T1D上，迄今为止还没有研究DD的不同方法减少直接最大程度地改善血糖控制的方式。为了解决这些问题我们提出针对使用理论支持的，证明的干预措施的T1D成年人进行的3臂临床试验测试通过情绪调节策略（TUNEDIN）直接针对DD的程序的附加值以及统一的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/疾病管理干预措施（Streamline）。主要结果是 HBA1C。我们将探索将DD的变化与HBA1C随时间变化的变化联系起来的中介途径。这选择性调节变量对干预效率的影响将被评估。干预费用和利益相关者的投入将为传播和未来计划实施提供信息。