Telehealth Intervention for Youth With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in Hemoglobin A1c
研究概览
简要总结
Hospitalization of youth with established diabetes is both costly and frequently preventable. Poor glycemic control is a risk factor for hospitalization and is also associated with adolescent age and lower socioeconomic status. This is a randomized, controlled trial for high-risk adolescent youth with T1DM and suboptimal glycemic control with an intervention arm and usual care control arm matched for frequency of contacts. There will be 110 subjects with T1DM and HbA1c>8%, aged 13 to 17 years, recruited from the Diabetes Program at Boston Children's Hospital and followed for 6 months. The intervention will be implemented by a diabetes nurse educator and social worker, who will each have monthly contact with the adolescent and a parent/guardian through a telehealth (videoconference) visit. Care will be guided by a diabetes action plan. Telehealth interventions have been utilized successfully in both adults and youth with diabetes. They facilitate frequent contact with the care team allowing barriers to adherence to be addressed, education to be reinforced, care plans to be updated, and diabetes-specific family support to be provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13 to 17 years
- •Type 1 diabetes for ≥1 year
- •HbA1c>8%
- •Able to speak and read English (Child)
- •Able to speak and read English (Parent)
- •Parent agrees to participate
- •Parent and child each have email addresses
排除标准
- •Plan to transition diabetes care to a center other than Boston Children's Hospital
- •No visit to Boston Children's Hospital Diabetes Program in year prior to recruitment
- •Current participation in another diabetes-related study with an intervention
- •Living with or related to another study participant
- •Significant psychopathology or medical illness that would limit the subject's ability to provide assent and/or participate in the study procedures as determined by the PI.
- •No internet access
结局指标
主要结局
Change in Hemoglobin A1c
时间窗: baseline and 6 months
Change in hemoglobin A1c over 6 months
次要结局
- Change in Adherence to diabetes self-management(Baseline and 6 months)
- % patients meeting ADA HbA1c target(At 6 months)
- Diabetes-related adverse events(Up to 6 months)
- Change in Health related quality of life(Baseline and 6 months)
- Change in Diabetes self-efficacy(Baseline and 6 months)
- Change in competence with diabetes skills(Baseline and 6 months)
- Change in Diabetes Knowledge(Baseline and 6 months)
研究者
Erinn T. Rhodes
Director of Endocrinology Healthcare Research and Quality
Boston Children's Hospital