Pilot Study: Intensive Education in a Residential Camp Setting for Families of Young Children With Type 1 Diabetes (TotCamp)
2017年6月21日 更新者：University of Texas Southwestern Medical Center
18 preschool aged children and their families will attend structured, multidisciplinary, family-centered intensive education sessions over a 3-day weekend in a residential camp setting to address the unique challenges of managing type 1 diabetes mellitus in young children.
A second 'booster' session, will be conducted 6 months later.
研究概览
详细说明
We propose to deliver a structured multidisciplinary family-centered intervention over a 3-day weekend, with a second similar "booster" session 6 months later. The intervention will be based at our regional diabetes camp, Camp Sweeney. The proposed camp encounters aim to provide:
- An opportunity for intensive education beyond that achievable in a single class, and without the unfavorable impacts of multiple weekday classes on family and work time.
- Varied educational modalities including didactic sessions, practical demonstrations and role playing.
- Close observation of each child throughout the day and night by experienced diabetes counselors and medical staff to identify and help correct maladaptive family behaviors.
- A safe environment where parents can participate in group therapy sessions without child care worries.
- An opportunity for age-appropriate child-centered educational and therapeutic activities.
- An opportunity for families to form mutually-supportive friendships.
- Fun weekends away where the parents have help caring for their diabetic children.
We will conduct this pilot study, which will enroll 18 preschool children age 3-5.5 years, with the goal of obtaining preliminary results for 15 subjects.
The primary outcome, to be determined approximately one month before and after each of the two camp sessions, is improvement in Hemoglobin A1c (HbA1c). This outcome will be compared with that of historical controls.
Exploratory Hypotheses:
Compared with pretreatment baseline and historical controls, subjects attending two 3-day sessions at a family diabetes camp will improve:
- HbA1c 3 months after the first camp session
- Hypoglycemia frequency, as measured by continuous glucose monitoring
- Medical system utilization, as measured by telephone call frequency and also by emergency room visits and hospitalizations
- Behavioral/QoL assessments, including the parents of young children version of the hypoglycemia fear survey (HFS-P-YC), the Behavioral Pediatrics Feeding Assessment Scale (BPFAS), and the general and diabetes modules of the PedsQL.
- Diabetes knowledge, assessed by questionnaire
- Development of friendships between subject families, assessed by questionnaire
研究类型
介入性
注册 (实际的)
18
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
2年 至 5年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 3-5.5 years old (+/- 2 months) at the date of first camp session they are eligible to join.
- Child and Parents fluent in either English or Spanish.
- Type 1 diabetes mellitus diagnosed for at least 10 months previous to date of first camp they are eligible to join.
- Taking insulin
- Custodial parent or guardian (preferable both parents or guardians) willing to attend both session of camp and the activities scheduled for them.
- Parent or guardian must sign consent before any study procedures are performed.
Exclusion Criteria:
- Neonatal diabetes (diagnosis in the first 3 months of life) or documented MODY; i.e., a likely genetic form of diabetes rather than an autoimmune etiology.
- Post-surgical diabetes (e.g., pancreatectomy for congenital hyperinsulinism). Such patients often cannot secrete glucagon, leading to a particularly severe inability to defend against hypoglycemia.
- Other severe chronic disease (e.g., cancer, cystic fibrosis) which in the judgment of the investigator is likely to significantly affect glycemic control.
- Patients cannot be taking systemic corticosteroids at enrollment because of adverse effects on glycemic control, but we will not disqualify subjects who require such therapy during the study. Inhaled or topical corticosteroids are permissible.
- Patients with hypothyroidism or hyperthyroidism must be clinically euthyroid and have free T4 and TSH within age-appropriate reference ranges at last medically indicated testing. Patients with out of range values may be retested after medication dose adjustment.
- Developmental delay or behavioral disorder in the patient of sufficient severity, in the judgment of the investigator, to interfere with group activities.
- Medical or psychiatric disorder in a parent of sufficient severity, in the judgment of the investigator, to interfere with group activities.
- Celiac disease is not an exclusion criterion.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Intensive Education
Attendance of 2 intensive education sessions
|
Participants will attend a 3 day family-centered, multidisciplinary, intensive education session at our regional diabetes camp, Camp Sweeney.
A second 'booster' session will be conducted 6 months later.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Hemoglobin A1c one month pre-camp to one month post-camp Session 1
大体时间：One month pre-camp, one month post-camp
|
As compared to historical controls
|
One month pre-camp, one month post-camp
|
|
Change in Hemoglobin A1c one month pre-camp to one month post-camp Session 2
大体时间：One month pre-camp, one month post-camp
|
As compared to historical controls
|
One month pre-camp, one month post-camp
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Hypoglycemia frequency one month pre-camp to one month post-camp Session 1
大体时间：One month pre-camp, one month post-camp
|
As measured by continuous glucose monitoring, and quantitated as area under the curve for blood glucoses <70 mg/dL.
|
One month pre-camp, one month post-camp
|
|
Change in Hypoglycemia frequency one month pre-camp to one month post-camp Session 2
大体时间：One month pre-camp, one month post-camp
|
As measured by continuous glucose monitoring, and quantitated as area under the curve for blood glucoses <70 mg/dL.
|
One month pre-camp, one month post-camp
|
|
Medical system utilization ( emergency room visits, hospitalizations related to T1DM)
大体时间：Duration of participation in study, expected to be 10 months
|
Composite measure.
As compared to historical controls.
|
Duration of participation in study, expected to be 10 months
|
|
Change in PedsQL Family Impact Module one month pre-camp to one month post-camp Session 1
大体时间：One month pre-camp, one month post-camp
|
Parent report
|
One month pre-camp, one month post-camp
|
|
Change in PedsQL Family Impact Module one month pre-camp to one month post-camp Session 2
大体时间：One month pre-camp, one month post-camp
|
Parent report
|
One month pre-camp, one month post-camp
|
|
Change in PedsQL Pediatric Quality of Life Inventory one month pre-camp to one month post-camp Session 1
大体时间：One month pre-camp, one month post-camp
|
Parent report for Toddlers, Parent report for Young Children, Young Child Report
|
One month pre-camp, one month post-camp
|
|
Change in PedsQL Pediatric Quality of Life Inventory one month pre-camp to one month post-camp Session 2
大体时间：One month pre-camp, one month post-camp
|
Parent report for Toddlers, Parent report for Young Children, Young Child Report
|
One month pre-camp, one month post-camp
|
|
Change in PedsQL Diabetes Module one month pre-camp to one month post-camp Session 1
大体时间：One month pre-camp, one month post-camp
|
Parent report for Toddlers, Parent report for Young Children, Young Child Report
|
One month pre-camp, one month post-camp
|
|
Change in PedsQL Diabetes Module one month pre-camp to one month post-camp Session 2
大体时间：One month pre-camp, one month post-camp
|
Parent report for Toddlers, Parent report for Young Children, Young Child Report
|
One month pre-camp, one month post-camp
|
|
Change in Hypoglycemia Fear Survey one month pre-camp to one month post-camp Session 1
大体时间：One month pre-camp, one month post-camp
|
Parents of young children version
|
One month pre-camp, one month post-camp
|
|
Change in Hypoglycemia Fear Survey one month pre-camp to one month post-camp Session 2
大体时间：One month pre-camp, one month post-camp
|
Parents of young children version
|
One month pre-camp, one month post-camp
|
|
Change in Behavioral Pediatrics Feeding Assessment one month pre-camp to one month post-camp Session 1
大体时间：One month pre-camp, one month post-camp
|
Behavior section
|
One month pre-camp, one month post-camp
|
|
Change in Behavioral Pediatrics Feeding Assessment one month pre-camp to one month post-camp Session 2
大体时间：One month pre-camp, one month post-camp
|
Behavior section
|
One month pre-camp, one month post-camp
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Perrin White, MD、UT Southwestern Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年7月1日
初级完成 (实际的)
2016年8月1日
研究完成 (实际的)
2017年1月1日
研究注册日期
首次提交
2015年3月10日
首先提交符合 QC 标准的
2015年4月28日
首次发布 (估计)
2015年5月4日
研究记录更新
最后更新发布 (实际的)
2017年6月23日
上次提交的符合 QC 标准的更新
2017年6月21日
最后验证
2017年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.