Evaluation of a Group Curriculum to Improve Self-Management Adherence and Transition Readiness in Older Teens With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline self-care adherence at 12 months
研究概览
简要总结
SMART T1D is a research study that offers interactive diabetes education for teens with type 1 diabetes in peer groups led by diabetes nurse educators. Participants in the study will be randomly assigned to either receive three of the group sessions in addition to their routine clinic care or to receive their usual diabetes clinic care.
详细描述
The objective of this 12-month pilot randomized controlled trial is to evaluate the impact of a 3-session group educational curriculum, compared to standard care, on self-care adherence and transition readiness in adolescents with type 1 diabetes in the Boston Children's Hospital (BCH) Diabetes Program. Adolescents (15-18 years) with T1D will be randomized to receive a 3-session group curriculum ("SMART T1D" - Self-Management, Adherence and Readiness for Transition in T1D) in addition to usual care (intervention group) or to receive usual care with individual diabetes visits (control group) and electronic newsletters to match for attention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in the pediatric diabetes clinic at Boston Children's Hospital
- •Age 15-18 years at enrollment
- •Diabetes duration >1 year
- •Ability to speak/read English
- •Visits to any BCH Diabetes Program site ≥1 times over the past 6 months
- •Hemoglobin A1c at clinic visit prior to enrollment 7.5%-11%
排除标准
- •Major medical or psychiatric comorbidities
- •Established patients of one of the diabetes nurse educators delivering the intervention
研究组 & 干预措施
Intervention Group
Participants in this group will receive 3 group education sessions led by a diabetes nurse educator in addition to standard care.
干预措施: Intervention (Behavioral)
Control Group
These participants will receive no intervention. They will have clinic care as usual and will receive three diabetes newsletters to match for attention.
结局指标
主要结局
Change from baseline self-care adherence at 12 months
时间窗: 12 months
Measured by the Self-Care Inventory-Revised (SCI-R)
次要结局
- Change from baseline hemoglobin A1c at 12 months(12 months)
- Change from baseline transition readiness at 12 months(12 months)
研究者
Katharine Garvey
Pediatric Endocrinologist
Boston Children's Hospital