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

基于家庭视频的远程医疗可减少幼儿家长对低血糖的恐惧

• 批准号: 10381509
• 负责人: Susana R Patton
• 金额: $ 57.45万
• 依托单位: NEMOURS CHILDREN'S CLINIC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10381509
• 关键词: Accelerometer; Address; Adherence; Adolescent and Young Adult; Adult; Aftercare; Age; Attention; Behavior; Behavioral; Blood Glucose; Blood Vessels; Child; Child Health; Child Rearing; Childhood; Cognitive Therapy; Complications of Diabetes Mellitus; Dangerousness; Data; Development; Event; Evidence based intervention; Family; Foundations; Fright; Future; Glucose; Glycosylated hemoglobin A; Goals; Health; Home; Hypoglycemia; Impairment; Individual; Informed Consent; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Intervention; Lead; Learning; Literature; Maintenance; Measures; Metabolic Control; National Institute of Diabetes and Digestive and Kidney Diseases; Outcome; Outcome Measure; Parents; Patients; Persons; Public Health; Quality of life; Randomized; Randomized Clinical Trials; Reporting; Research; Risk; School-Age Population; Seizures; Specific Phobia; Stratification; Stress; Surveys; Symptoms; Technology; Telemedicine; Time; Training; Work; Youth; analog; attentional control; avoidance behavior; base; diabetes education; diabetes risk; diabetes self-management; effective therapy; efficacy testing; emotional distress; experience; follow up assessment; follow-up; glucose monitor; glycemic control; improved; innovation; programs; recruit; satisfaction; sex; treatment comparison; treatment effect; trial comparing

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.

项目概要/摘要 患有 1 型糖尿病 (T1D) 的幼儿仍然极易发生低血糖，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)。父母和年轻人 患有 T1D 的儿童很快就会害怕低血糖，因为低血糖让人感觉不舒服、尴尬、看似 不可预测，并且存在潜在危险。事实上，研究表明，年幼孩子的父母报告高 中度至重度低血糖恐惧（FH）的发生率。不幸的是，FH 会导致两个问题： 质量受损 提高儿童血糖水平导致持续代谢不良的生活和补偿行为 控制（HbA1c）和长期血管并发症的风险增加。响应关键需求 为了治疗幼儿家庭中父母家族性高胆固醇血症的干预措施，我们开发了一种创新的基于视频的方法 远程医疗干预，称为 REDCHiP（减少儿童低血糖的情绪困扰） 父母）。 REDCHiP 在 10 项研究中使用认知行为疗法、T1D 教育和行为家长培训。 会议以个人和团体为基础的远程医疗计划，以减少家长 FH 并教家长如何 改变低血糖回避行为。在我们的试点工作中，我们发现 REDCHiP 的初步功效 减少父母 FH、养育压力和儿童 HbA1c。 R01 的目标是进行 在家庭中将 REDCHiP 与相关注意力控制干预措施 (ATTN) 进行比较的随机临床试验 (RCT) 幼儿，从而继续确定其功效。拟议的 R01 目标是： 1) 评估 接受 REDCHiP 治疗的父母是否报告治疗后 FH 和育儿压力有所减少 收到 ATTN 的家长； 2) 评估接受 REDCHiP 的父母的孩子是否有 与接受 ATTN 的父母的孩子相比，治疗后的 HbA1c 更低，血糖变异性更小； 3) 检查 3 个月内 FH、育儿压力和儿童 HbA1c 改善的维持情况 后续行动。我们将招募 180 个家庭，目标是通过 3 个月的随访保留至少 144 个家庭。后 知情同意后，我们将随机将父母分配至 REDCHiP 或 ATTN，并让他们完成基线 措施（例如家长调查、儿童血糖传感、儿童/家长加速度测量和儿童 HbA1c）。然后， 两组家长将参加 10 场时间和形式相匹配的视频远程医疗课程 （团体v个人）。治疗后，家长和孩子将重复基线评估；在3个月的时候 接下来，家长将完成调查，孩子将接受葡萄糖传感和糖化血红蛋白 (HbA1c)。的影响 拟议的 R01 较高，因为父母 FH 很常见，并且与 T1D 自我保健不良和儿童血糖有关 控制，这可能会导致当前和未来昂贵且危险的并发症。它是创新的，因为 其使用基于视频和基于团体的远程医疗的情况，这响应了 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 的功效是我们的下一步计划 研究计划，并可能产生一种有效且可扩展的治疗方法，可以改善儿童的健康。