An Interactive mHealth App for Better Glycemic Control in Parents of Young Kids With T1D
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Parent Depressive Symptoms
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
- 否
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).
研究组 & 干预措施
DIPPer Academy
Parents randomized to this group will participate in the DIPPer Academy curriculum.
干预措施: DIPPer Academy (Behavioral)
Standard of Care Control
Parents randomized to this group will receive care as usual from their child's diabetes provider
干预措施: Standard of Care (Other)
结局指标
主要结局
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
Child Glycemic Control
时间窗: absolute value Post-treatment (Week 33)
Measure of hemoglobin A1c (HbA1c).
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))