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临床试验/NCT03385265
NCT03385265已完成不适用

An Interactive mHealth App for Better Glycemic Control in Parents of Young Kids With T1D

University of Kansas Medical Center4 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
4
主要终点
Child Glycemic Control

研究概览

简要总结

The purpose of this research is to develop DIPPer Academy, a parent-focused, mobile health (mHealth) behavioral intervention to promote glycemic control in young children.

详细描述

Because many young children with T1D have glucose levels that exceed targets, investigators need to develop efficacious, accessible, and readily disseminable interventions to help them to improve their glycemic control. To do this, the investigators need efficacious interventions that specifically address the challenges that parents of young children face in daily T1D management. Providers need mHealth interventions that minimize barriers that parents experience when trying to access face-to-face or in clinic interventions. Finally, interventions are needed that are packaged to be easily deployable by other diabetes centers. The investigator's proposed intervention, DIPPer Academy, will include all of these recommended advancements.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
3 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parents of a young child who is between 3-5.99 years old and at least 6 months post T1D diagnosis
  • Parents who are English-speaking.

排除标准

  • Parents of young children with evidence of type 2 diabetes or monogenic diabetes.
  • Parents with evidence of severe psychiatric disorder.
  • Parents of young children with a comorbid chronic illness (e.g., renal disease) that requires ongoing care beyond T1D.
  • Parents of young children with a history of anemia or medication use that may interact with glycemic control (e.g., systemic steroids).

结局指标

主要结局

Child Glycemic Control

时间窗: absolute value Post-treatment (Week 33)

Measure of hemoglobin A1c (HbA1c).

Parent Depressive Symptoms

时间窗: absolute value Post-treatment (Week 33)

Center for Epidemiological Studies-Depression Scale Revised (CES-D); higher scores suggest worse outcome. Range 0-60.

Parent Diabetes Distress

时间窗: Absolute value at Post-treatment (Week 33)

Problem Areas in Diabetes Distress- Parent Report Questionnaire. Higher scores reflect worse outcome. Range 0-72

次要结局

  • Family Mealtime behaviors_Frequency(absolute value at Post-treatment (Week 33))
  • Parents' Hypoglycemia Fear(absolute value at Post-treatment (Week 33))
  • Parenting Stress- Frequency(Absolute value at Post-treatment (Week 33))
  • Parents' T1D Self-efficacy(Absolute value at Post-treatment (Week 33))
  • Parent Knowledge of T1D(Absolute value at Post-treatment (Week 33))
  • Behavioral Pediatric Feeding Assessment Scale_Problem(Absolute value at Post-treatment (Week 33))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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