Home Video-Based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children

项目摘要/摘要 患有1型糖尿病(T1D)的幼儿仍然非常容易发生低血糖，尽管 推出新的胰岛素类似物、胰岛素泵和连续血糖监测仪(CGM)。父母和孩子 患有T1D的儿童很快就会学会害怕低血糖，因为它让人不舒服，令人尴尬，看起来 不可预测，而且具有潜在的危险。事实上，研究表明，年幼孩子的父母报告说 中度至重度低血糖恐惧率(FH)。不幸的是，FH导致了两个问题：质量受损 生活和代偿行为导致儿童血糖水平升高，导致持续的代谢不良 控制(HbA1c)和增加长期血管并发症的风险。满足以下关键需求 干预措施在治疗父母FH的家庭中，我们开发了一种创新的基于视频的 远程医疗干预，称为RedChip(减少儿童低血糖的情绪困扰) 父母)。RedChip使用认知行为疗法、T1D教育和行为父母培训在10- 以个人和团体为基础的会议远程医疗计划，以减少父母的FH，并教父母如何 改变低血糖回避行为。在我们的试点工作中，我们发现RedChip在 减少父母的FH，养育压力，和孩子的糖化血红蛋白。本R01的目标是进行一项 随机临床试验(RCT)比较红筹与相关注意力控制干预(ATTN)在家庭中的应用 因此，继续确立其功效。建议的R01目标是：1)评估 接受红筹治疗的父母是否报告治疗后FH和养育压力的减少进行了比较 给收到红筹的父母；2)评估收到红筹的父母的孩子是否有 与接受ATTN治疗的父母的孩子相比，治疗后HbA1c和血糖变异性较低； 3)在3个月内检查FH、父母压力和儿童HbA1c的持续改善情况 后续行动。我们将招募180个家庭，目标是在3个月的随访中至少保留144个家庭。之后 知情同意，我们将随机选择红筹或Attn的父母，并让他们完成基线 测量方法(例如，家长调查、儿童血糖监测、儿童/家长加速计和儿童HbA1c)。然后, 两组的父母都将参加10次基于视频的远程医疗会议，时间和形式都是匹配的 (团体对个人)。在治疗后，父母和孩子将重复基线评估；在3个月时 随后，父母将完成调查，孩子将接受血糖检测和糖化血红蛋白检测。网络的影响 建议的R01很高，因为父母的FH很常见，而且与T1D自理能力差和儿童血糖升高有关 控制，这可能导致昂贵和危险的目前和未来的并发症。它的创新之处在于 使用基于视频和基于组的远程医疗，以响应NIDDK倡议以及潜在的 可扩展到更小的T1D中心。在更大的RCT中测试RedChip的有效性是我们合理的下一步 研究计划，并可能产生一种有效的和可扩展的治疗方法，可以改善儿童的健康。

PROJECT SUMMARY/ABSTRACT Young children with type 1 diabetes (T1D) remain highly vulnerable to episodes of hypoglycemia despite the introduction of new insulin analogs, insulin pumps, and continuous glucose monitors (CGM). Parents and young children living with T1D quickly learn to fear hypoglycemia because it is uncomfortable, embarrassing, seemingly unpredictable, and potentially dangerous. Indeed, research shows that parents of young children report high rates of moderate to severe hypoglycemia fear (FH). Unfortunately, FH leads to two problems: impaired quality of life and compensatory behaviors that raise children’s blood glucose levels leading to on-going poor metabolic control (HbA1c) and an increased risk for long-term vascular complications. Responding to a critical need for interventions to treat parental FH in families of young children, we developed an innovative video-based telemedicine intervention, called REDCHiP (Reducing Emotional Distress for Childhood Hypoglycemia in Parents). REDCHiP uses cognitive behavioral therapy, T1D education, and behavioral parent training in a 10- session individual and group-based telemedicine program, to reduce parental FH and to teach parents how to change hypoglycemic avoidance behaviors. In our pilot work, we found preliminary efficacy for REDCHiP in reducing parental FH, parenting stress, and children’s HbA1c. The objective of this R01 is to conduct a randomized clinical trial (RCT) comparing REDCHiP to a relevant attention control intervention (ATTN) in families of young children, thereby continuing to establish its efficacy. The proposed R01 aims are: 1) To evaluate whether parents who receive REDCHiP report reductions in FH and parenting stress at post-treatment compared to parents who receive the ATTN; 2) To evaluate whether children of parents who receive REDCHiP have a lower HbA1c and less glycemic variability at post-treatment compared to children of parents who receive ATTN; 3) To examine for maintenance of improvements in FH, parenting stress, and children’s HbA1c in a 3-month followup. We will recruit 180 families with the goal of retaining at least 144 through the 3-month followup. After informed consent, we will randomize parents to either REDCHiP or ATTN and have them complete baseline measures (e.g., parent surveys, child glucose sensing, child/parent accelerometry, and child HbA1c). Then, parents in both groups will participate in 10 video-based telemedicine sessions matched for time and format (group v individual). At post-treatment, parents and children will repeat the baseline assessment; at the 3-month followup, parents will complete surveys and children will undergo glucose sensing and an HbA1c. The impact of the proposed R01 is high because parental FH is common and relates to poor T1D self-care and child glycemic control, which can lead to expensive and dangerous present and future complications. It is Innovative because of its use of video- and group-based telemedicine which is responsive to NIDDK initiatives as well as potentially scalable to even smaller T1D centers. Efficacy testing REDCHiP in a larger RCT is the logical next step in our research program and likely to yield an effective and scalable treatment that can improve children’s health.