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

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。

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.