Patton Susana R, McConville Andrew, Marker Arwen M, Monzon Alexandra D, Driscoll Kimberly A, Clements Mark A
Nemours Children's Health System, Jacksonville, FL, United States.
Clinical Child Psychology Program, University of Kansas, Lawrence, KS, United States.
JMIR Res Protoc. 2020 Aug 18;9(8):e17877. doi: 10.2196/17877.
Despite the introduction of new insulin analogs, insulin pumps, and continuous glucose monitoring (CGM), young children with type 1 diabetes mellitus (T1D) remain vulnerable to episodes of hypoglycemia because of their unpredictable eating and activity patterns and high degree of insulin sensitivity. Caregivers and young children living with T1D learn to fear hypoglycemia because it is uncomfortable, unpredictable, and dangerous. Up to 60% of caregivers of young children with T1D report moderate to severe levels of fear of hypoglycemia, and caregiver fear of hypoglycemia relates to lower quality of life for families and suboptimal child glycemic control. Yet, until recently, there have been no studies reporting on a targeted intervention to treat caregiver fear of hypoglycemia in families of young children.
The aim of this project is to conduct a randomized clinical trial of an innovative, video-based telehealth intervention to treat fear of hypoglycemia in caregivers of young children with T1D versus a relevant, age-appropriate attention control intervention.
We created the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention by merging age-appropriate T1D education and behavioral parenting strategies with cognitive behavioral therapy strategies that are effective for reducing fear and promoting adaptive coping. REDCHiP uses 10 video-based telehealth sessions that are a combination of group and individual sessions. We will recruit up to 180 families of young children with T1D to participate in this clinical trial from two pediatric diabetes clinics located in the midwestern and southern United States. Once families have been enrolled, we will randomize caregivers based on child age (age 2-3 years or 4-5 years), child sex, and family CGM use to participate in the REDCHiP or attention control intervention. Families will complete 3 assessment visits that coincide with study entry, end of treatment, and 3-month posttreatment. At each assessment visit, we will collect questionnaire data from caregivers, accelerometry data from caregivers and children, CGM data from children, and a blood sample to measure glycated hemoglobin levels from children.
Recruitment began in July 2019, and enrollment is ongoing. The first wave of intervention delivery began in December 2019. We anticipate completing enrollment in 2023. Final reporting of results will occur within 12 months of the primary completion date.
If the REDCHiP intervention is efficacious, next steps will be to examine multiple implementation strategies to determine how best to disseminate the intervention to pediatric diabetes clinics around the world.
ClinicalTrials.gov NCT03914547; https://clinicaltrials.gov/ct2/show/NCT03914547.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/17877.
尽管新型胰岛素类似物、胰岛素泵及持续葡萄糖监测（CGM）已被应用，但1型糖尿病（T1D）幼儿仍易发生低血糖，原因在于他们的饮食和活动模式不可预测，且胰岛素敏感性高。T1D患儿的照料者和患儿会因低血糖不适、不可预测且危险而对其产生恐惧。高达60%的T1D幼儿照料者报告称对低血糖有中度至重度恐惧，照料者对低血糖的恐惧与家庭生活质量较低及患儿血糖控制欠佳有关。然而，直到最近，尚无研究报道针对T1D幼儿家庭中照料者对低血糖恐惧的靶向干预措施。
本项目旨在开展一项随机临床试验，比较一种创新的基于视频的远程医疗干预措施与一种相关的、适合年龄的注意力控制干预措施，以治疗T1D幼儿照料者对低血糖的恐惧。
我们通过将适合年龄的T1D教育及行为养育策略与对减轻恐惧和促进适应性应对有效的认知行为疗法策略相结合，创建了“降低儿童低血糖家长情绪困扰”（REDCHiP）干预措施。REDCHiP采用10次基于视频的远程医疗课程，包括小组课程和个别课程。我们将从美国中西部和南部的两家儿科糖尿病诊所招募多达180个T1D幼儿家庭参与这项临床试验。家庭入组后，我们将根据儿童年龄（2至3岁或4至5岁）、儿童性别及家庭CGM使用情况，将照料者随机分配至REDCHiP或注意力控制干预组。家庭将在研究开始、治疗结束及治疗后3个月完成3次评估访视。每次评估访视时，我们将收集照料者的问卷数据、照料者和儿童的加速度计数据、儿童的CGM数据以及一份血样以测量儿童糖化血红蛋白水平。
招募工作于2019年7月开始，目前仍在进行中。第一波干预于2019年12月开始。我们预计在2023年完成入组。结果的最终报告将在主要完成日期后的12个月内完成。
如果REDCHiP干预措施有效，下一步将研究多种实施策略，以确定如何最好地将该干预措施推广至全球的儿科糖尿病诊所。
ClinicalTrials.gov NCT03914547；https://clinicaltrials.gov/ct2/show/NCT03914547。
国际注册报告识别码（IRRID）：PRR1-10.2196/17877。
