应对技能训练项目在湖南省青少年1型糖尿病患者中的应用效果及其机制研究

Background: Type 1 Diabetes (T1D) is the most common and severe metabolic disorder of childhood. How to help the youth strengthen the ability of diabetes management and improve the level of adaptation to T1D in adolescents is a global concern. Our previous research found that the processes and outcomes of adapting to T1D are sub-optimal in adolescents with T1D, especially for Chinese adolescents. Coping Skill Training for adolescents with T1D (CST) was developed to promote children’s adaptation to T1D in the United States, which had a positive effect in adaptation outcomes of metabolic control and quality of life. However, the major interventions for Chinese adolescents were regular diabetes education with limited effect on diabetes adaptation improvement. .Objectives：To adopt CST of the US version to Chinese culture and healthcare system, to determine the effect of CST on adaptation process and outcomes in Chinese adolescents with T1D, and to explore the mechanism of CST program..Methods: This is a randomized clinical trial. In total 108 adolescents with T1D who range in age from 12 to 20 years will be recruited. All providers will be blinded to the study group assignment of the participants. Subjects will be randomly assigned to the treatment group or control group. Both groups will be invited to a three-day diabetes camp, only the subjects in the experimental group will take CST program, the subjects in the control group will take regular diabetes education related to diabetes management targeted to this age group.. Data will be collected at baseline, after CST program, and 6 months for all the adaption outcome variables and process variables, along with satisfaction of CST program and a few health economic variables. The adaption outcome of physiologic [Hemoglobin A1c (HbA1c)] and psychosocial [satisfaction with quality of life (QOL)], as well as adaption process variables of self-management, coping, depressive symptoms, and self-efficacy, will be used to evaluate the effect of CST. The satisfaction with CST program via diabetes camp and a few health economic variables will also be measured. The mediation analysis of the mediation effect of self-management, coping, and self-efficacy on adaptation outcomes will be used to explore the mechanism of CST program. .Significance: This proposed study will be the first attempt to extend CST to a broader audience oversea and to determine if the modification of CST to a mode of Chinese culture and Chinese healthcare system will improve adaptation to T1D in Chinese population.

1型糖尿病（T1DM）是儿童时期最常见、最严重的代谢紊乱性疾病。如何帮助患者提高疾病管理能力、改善疾病适应结局已经引起全球关注。前期研究发现湖南省青少年T1DM患者的疾病适应现状较差。青少年T1DM应对技能训练（CST）是著名的改善患者疾病适应状况的项目，但目前国内针对这一人群疾病适应方面的干预手段仅限于糖尿病教育。本项目拟探讨汉化版CST项目对改善青少年T1DM患者疾病适应状况的效果及其作用机制。采用临床随机对照试验研究方法，对照组参加常规夏令营（以糖尿病教育为主），实验组参加常规夏令营+CST干预。探讨基线、干预结束、干预后6个月两组患者在疾病适应结局和适应过程方面的差别及相关卫生经济学指标，分析中介变量和调节变量对适应结局的作用效果。本项目系首次在我国应用并评价CST项目对改善青少年T1DM患者疾病适应状况的效果，有望提高患者的疾病适应水平，同时形成卫生政策报告，具有推广应用前景。

1型糖尿病（T1D）是严重威胁儿童和青少年健康的慢性疾病。如何帮助患者提高疾病管理能力、改善疾病适应结局已经引起全球关注。前期研究发现湖南省青少年T1D患者的疾病适应现状较差。青少年T1D应对技能训练（CST）是著名的改善患者疾病适应状况的项目，但目前国内针对这一人群疾病适应方面的干预手段仅限于糖尿病教育。.本项目在前期研究工作基础上，探讨了汉化版CST项目对改善青少年T1D患者疾病适应状况的效果及其作用机制。采用临床随机对照试验研究方法，对照组参加常规夏令营（以糖尿病教育为主），实验组参加常规夏令营+CST干预。探讨基线、干预结束、干预后6个月两组患者在疾病适应结局和适应过程方面的差别，分析中介变量和调节变量对适应结局的作用效果。.本项目重要结果：（1）基于知觉压力、应对方式、自我效能和生活质量满意度之间的假设关系，结构方程模型拟合情况良好，暴力宣泄应对方式和自我效能在知觉压力和生活质量满意度之间起中介作用。（2）知觉压力对糖尿病自我管理的直接效应不显著，自我效能在二者之间起中介作用；知觉压力与自我效能呈显著负相关（p<0.05）；交互作用结果显示,患者在低压力水平且具有较高自我效能的情况下，糖尿病自我管理水平最高(ps<0.05)。（3）与常规糖尿病教育相比，进行CST干预的学龄期T1D患者在自我效能、糖尿病自我管理方面均有所改善；但是进行CST干预的青少年T1D患者各变量间的差异无统计学意义。.本项目系首次把国外的CST项目应用到我国儿童青少年T1D人群，结果提示医护人员在对患者进行糖尿病自我管理教育时，应以减压为目标，引导患儿更多地采取积极应对方式，尽量减少消极应对方式如暴力宣泄，同时提高自我效能以实现最佳的糖尿病自我管理。在今后开展CST干预时，应将儿童和青少年分开，或者根据青少年患者的特点，对现场CST进行改良，针对青少年患者进行特殊的引导和内容设置，并以互联网技术为载体开展相关项目，可能可以帮助其提高对疾病的适应能力。