'Parent-Child Co-Regulation of Pediatric Diabetes'

《小儿糖尿病亲子共同调控》

• 批准号: 6544561
• 负责人: Linda Ann Gonder-Frederick
• 金额: $ 30.3万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2006-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6544561
• 关键词: awareness; clinical research; clinical trials; computer assisted patient care; data collection methodology /evaluation; diabetes education; diabetes mellitus therapy; disease /disorder prevention /control; health behavior; human therapy evaluation; hypoglycemia; insulin dependent diabetes mellitus; longitudinal human study; medical complication; middle childhood (6-11); outcomes research; parent offspring interaction; patient care management; patient monitoring device; patient oriented research; self care; training

DESCRIPTION (provided by applicant): Successful diabetes management relies on a process of self-regulation in which treatment behavior is guided by feedback about changing blood glucose (BG) levels and decision-making. The processes involved in self-regulation have been studied extensively in adults with Type 1 Diabetes Mellitus (T1DM), leading to the development of sophisticated research tools that have significantly advanced our understanding and ability to predict clinical outcome. Additionally, this research has led to the development of a highly effective, empirically based, psychobehavioral intervention, Blood Glucose Awareness Training (BGAT), developed by our research team, that improves self-regulation and clinical outcome in adults with T1DM. Unfortunately, the processes involved in the self-regulation of pediatric diabetes have received virtually no empirical attention. The purpose of the proposed project is to correct this scientific neglect by adapting the conceptual and methodological tools used in adult studies to 1) investigate the process of diabetes regulation by school-aged children (6-11 yrs) with T1DM and their parents and 2) develop and test an intervention to enhance the skills critical to this process. This is an important population to target for this line of inquiry because: 1) children with T1DM and their parents appear to be far less accurate than adult patients in symptom and BG detection; 2) As a group, pediatric patients are more likely to suffer from negative clinical sequelae (e.g., severe hypoglycemia (SH) and DKA); and, 3) Early intervention could have greater public health care benefit by achieving more reductions in acute and long-term complications, health care utilization, and disability. Phases 1A and 1B of the proposed project will provide the first systematic and comprehensive study of symptom recognition, BG detection, decision-making, and subsequent clinical sequelae in school-aged children with T1DM and their parents. A theoretical model of co-regulation of pediatric diabetes is proposed and tested, in which the behaviors of both parent and child influence the sequence of events that determine avoidance or occurrence of negative outcomes, such as extreme hypo- and hyperglycemia. Based on the findings of these studies and our current BGAT for adults, Phase 1 C will pilot test a translation of this intervention designed for parents of school-aged children with T1DM, BGAT for parents (BGAT-P). This intervention will take advantage of the critical role parents play as the primary teachers of children about diabetes management by including training activities for parents to do with their children designed to improve children's ability to recognize BG symptoms, detect extremes in BG, and make appropriate self-treatment decisions. Based on the findings from this pilot study, and feedback from parents, in Phase 2 BGAT-P will be further refined and tested in a controlled clinical trial to assess its short-term efficacy. Phase 3 is a 12-month follow-up study to determine whether the improvements found in Phase 2 are maintained over time and also to assess the impact of BGAT-P on future clinical negative events, including frequency of SH and DKA experienced by children.

描述（由申请人提供）：成功的糖尿病管理依赖于自我调节过程，其中治疗行为由关于血糖（BG）水平变化和决策的反馈指导。参与自我调节的过程已在1型糖尿病（T1 DM）成人中进行了广泛的研究，导致开发了复杂的研究工具，大大提高了我们的理解和预测临床结果的能力。此外，这项研究还开发了一种高效、基于经验的心理行为干预措施，即由我们的研究团队开发的血糖意识培训（BGAT），可以改善T1 DM成人的自我调节和临床结果。不幸的是，涉及儿童糖尿病的自我调节过程几乎没有得到经验的关注。本拟议项目的目的是通过调整成人研究中使用的概念和方法工具来纠正这种科学忽视，以1）调查学龄T1 DM儿童（6-11岁）及其父母的糖尿病调节过程，2）开发和测试干预措施，以增强对该过程至关重要的技能。这是这一系列调查的重要目标人群，因为：1）T1 DM儿童及其父母在症状和BG检测方面似乎远不如成人患者准确; 2）作为一个群体，儿科患者更有可能出现阴性临床后遗症（例如，严重低血糖（SH）和DKA）;和，3）早期干预可以有更大的公共卫生保健效益，实现更多的减少急性和长期并发症，卫生保健利用，和残疾。拟议项目的第1A和1B阶段将首次对学龄T1 DM儿童及其父母的症状识别、血糖检测、决策和随后的临床后遗症进行系统和全面的研究。提出并检验了儿童糖尿病协同调节的理论模型，在该模型中，父母和孩子的行为都会影响决定避免或发生负面结果（如极端低血糖和高血糖）的事件序列。根据这些研究的结果和我们目前针对成人的BGAT，1C期将对针对学龄T1 DM儿童父母的干预措施进行初步测试，针对父母的BGAT（BGAT-P）。这项干预措施将利用父母作为儿童糖尿病管理的主要教师所发挥的关键作用，包括为父母提供培训活动，以提高儿童识别BG症状的能力，检测BG的极端情况，并做出适当的自我治疗决定。根据这项试点研究的结果和家长的反馈，在第二阶段，BGAT-P将进一步完善，并在对照临床试验中进行测试，以评估其短期疗效。3期是一项为期12个月的随访研究，旨在确定2期中发现的改善是否随时间推移而保持，并评估BGAT-P对未来临床阴性事件的影响，包括儿童发生SH和DKA的频率。