Technology Knowledge Optimization in Type 1 Diabetes (TeKnO T1D): Parents
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Perceived Intervention Utility
研究概览
简要总结
This study aims to identify the unmet psychoeducational needs of parents of children 8-12 years of age using insulin pump and CGM for pediatric T1D management and to leverage that information to develop an innovative app-based psychoeducational intervention to optimize use of these technologies and improve T1D outcomes.
详细描述
Despite increased use of insulin pumps and continuous glucose monitors (CGM) for pediatric type 1 diabetes (T1D) management and research studies showing benefits from the use of these devices, real-world glycemic control among youth with T1D has worsened in recent years. Although greater youth and parental diabetes knowledge is associated with better glycemic control, education alone is not sufficient to bring about the behavioral changes needed to improve outcomes in T1D. Psychoeducation recognizes the need to blend educational and behavioral approaches, including problem-solving and goal-setting, to support parents in developing optimal T1D management approaches. There are currently a lack of effective standardized tools to support patients and families in developing the knowledge and behavioral strategies needed to optimize the use of diabetes technologies. The development of innovative family-centered psychoeducational tools addressing both behavior and knowledge will help to realize the full potential of diabetes technologies to improve glycemic control and quality of life while ultimately preventing or delaying the development of both acute and long-term complications of T1D.
Interviews with parent-child dyads and diabetes clinicians will be used to identify the unmet parental psychoeducational needs regarding insulin pumps and CGM. These results will inform the use of instructional design to adapt an existing app-delivered diabetes technology curriculum to meet the specific needs of parents of children with T1D. Finally, the investigators will assess the feasibility and acceptability of this novel family-facing psychoeducational app-delivered intervention in a non-randomized pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child 8-12 years of age with a diagnosis of T1D ≥ 6 months
- •currently using insulin pump( IP) and CGM ≥ 1 month [including Hybrid Closed Loop (HCL) systems]
- •participation of primary diabetes caregiver
- •English fluency
- •mean A1c >7.5% over the past 6 months (Aim 3 only)
排除标准
- •major illnesses other than T1D in the child
- •significant cognitive limitations or major psychiatric disorders in the child or parent
- •the use of medications other than insulin to control blood glucose levels.
结局指标
主要结局
Perceived Intervention Utility
时间窗: Arm 3: Months 30-60
Score on a survey developed to assess the perceived utility of the Technology Knowledge Optimization Type 1 Diabetes: Parents curriculum during Arm 3. Scores range from 0-100 with higher scores reflecting greater perceived utility.
Intervention Retention
时间窗: Arm 3: Months 30-60
Percentage of enrolled participants who complete the entire intervention for Arm 3.
Study Recruitment
时间窗: Arm 3: Months 30-60
Percentage of eligible patients who are approached and enroll in the study in Arm 3.
Intervention Satisfaction
时间窗: Arm 3: Months 30-60
Score on a survey developed to assess satisfaction with the Technology Knowledge Optimization Type 1 Diabetes: Parents curriculum in Arm 3. Scores range from 0-100 with higher scores reflecting greater satisfaction.
Intervention Completion
时间窗: Arm 3: Months 30-60
Percentage of enrolled participants who complete the TeKnO T1D: Parents Curriculum in Arm 3.
次要结局
- Parent Diabetes Self-Management(Arm 3: Months 30-60)
- Total Daily Insulin Dose(Arm 3: Months 30-60)
- Number of boluses per day(Arm 3: Months 30-60)
- Hospital Admissions(Arm 3: Months 30-60)
- Child Emotional Distress Related to T1D(Arm 3: Months 30-60)
- CGM Wear Time(Arm 3: Months 30-60)
- Emergency Department Visits(Arm 3: Months 30-60)
- Child Diabetes Self-Management(Arm 3: Months 30-60)
- Episodes of Diabetic Ketoacidosis(Arm 3: Months 30-60)
- Parent Diabetes-Specific Quality of Life(Arm 3: Months 30-60)
- Parent Emotional Distress Related to T1D(Arm 3: Months 30-60)
- Parent Diabetes Technology Knowledge(Arm 3: Months 30-60)
- Hemoglobin A1c(Arm 3: Months 30-60)
- CGM Mean Sensor Glucose(months 0-60)
- CGM Glucose Management Indicator(Arm 3: Months 30-60)
- CGM Coefficient of Variation of the Mean(Arm 3: Months 30-60)
- CGM Time in Range (70-180 mg/dL)(Arm 3: Months 30-60)
- CGM Time Below Range (<70 mg/dL)(Arm 3: Months 30-60)
- CGM Time Above Range (<180 mg/dL)(Arm 3: Months 30-60)
- Total Daily Basal Insulin Dose(Arm 3: Months 30-60)
- Percent Basal Insulin Dose(Arm 3: Months 30-60)
- Episodes of Severe Hypoglycemia(Arm 3: Months 30-60)
- Carbohydrate intake logged on insulin pump(Arm 3: Months 30-60)
- Parent Perceived CGM Benefits and Burdens(months 0-60)
- Child Diabetes-Specific Quality of Life(Arm 3: Months 30-60)
- Child Perceived CGM Benefits and Burdens(Arm 3: Months 30-60)