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

项目概要/摘要 1型糖尿病（T1 D）的幼儿仍然非常容易发生低血糖， 新的胰岛素类似物、胰岛素泵和连续血糖监测仪（CGM）的引入。父母和年轻 患有T1 D的儿童很快就学会了害怕低血糖，因为它不舒服，尴尬，似乎 不可预测而且有潜在危险事实上，研究表明，幼儿的父母报告说， 中度至重度低血糖恐惧（FH）的发生率。不幸的是，FH导致两个问题：受损的质量 生活和补偿行为，提高儿童的血糖水平，导致持续的代谢不良， 控制（HbA 1c）和长期血管并发症的风险增加。满足下列方面的迫切需要 干预措施，以治疗父母FH在家庭的幼儿，我们开发了一个创新的视频为基础的 远程医疗干预，称为REDCHiP（减少儿童低血糖症的情绪困扰） 父母）。REDCHiP使用认知行为疗法，T1 D教育和行为父母培训， 会议个人和小组为基础的远程医疗计划，以减少父母FH和教父母如何 改变低血糖回避行为。在我们的试点工作中，我们发现REDCHiP在以下方面的初步疗效： 降低父母FH、父母压力和儿童HbA 1c。本R 01的目标是进行 在家庭中比较REDCHiP与相关注意力控制干预（ATTN）的随机临床试验（RCT） 幼儿，从而继续建立其效力。建议的R 01目标是：1）评估 接受REDCHiP的父母是否报告治疗后FH和养育压力的减少， 2）评估接受REDCHiP的父母的孩子是否有一个 与父母接受ATTN的儿童相比，治疗后HbA 1c更低，血糖变异性更小; 3)检查FH、父母压力和儿童HbA 1c在3个月内的改善维持情况 跟进。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。后 知情同意后，我们将父母随机分配至REDCHiP或ATTN，并让他们完成基线检查 措施（例如，父母调查、儿童葡萄糖感测、儿童/父母加速度计和儿童HbA 1c）。然后， 两组的家长将参加10个基于视频的远程医疗会议， （组v个人）。在治疗后，父母和孩子将重复基线评估;在3个月时， 随访期间，父母将完成调查，儿童将接受葡萄糖感知和HbA 1c。的影响 建议的R 01较高，因为父母FH很常见，且与T1 D自我护理和儿童血糖相关 控制，这可能导致昂贵和危险的当前和未来的并发症。创新，因为 它使用基于视频和群组的远程医疗，这是对NIDDK倡议的响应， 可扩展到更小的T1 D中心。在一个更大的随机对照试验中测试REDCHiP的有效性是我们研究的合乎逻辑的下一步。 研究计划，并可能产生一个有效的和可扩展的治疗，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.