Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes: A Randomized Controlled Trial of SHIFT2
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Hemoglobin A1C (HbA1C)
研究概览
简要总结
The purpose of this research study is to evaluate a transition preparation program designed for adolescents and young adults (AYAs) with type 1 diabetes (T1D). This transition program will support AYAs as they prepare to transition from pediatric to adult endocrinology medical care and will also include a caregiver. Results from this study will inform clinical recommendations regarding self-management best practices for AYAs with T1D prior to transitioning to adult medical care.
详细描述
Investigators will recruit adolescents and young adults ages 16-22 years with T1D and a parent/guardian. Families will participate in one of two 6-month treatments: 1) SHIFT2, engaging in monthly sessions with transition coaches providing education on diabetes management and healthcare transition, or 2) Enhanced treatment (TAU+), engaging in routine medical care and receiving monthly education (no coaches).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes diagnosis for at least 1 year (as documented in medical record)
- •16-22 years old
- •English speaking
- •Children's Hospital of Richmond patient (Division of Pediatric Endocrinology)
- •must have a caregiver willing to participate
- •Age greater than 18 years
- •Provides care to AYA and willing to participate
排除标准
- •Non-English speaking
- •Significant psychiatric, cognitive, medical or developmental conditions that would impair their ability to complete assessments and/or engage in diabetes self-care behaviors (e.g., malignancies, psychosis, intellectual disability
- •Hospitalization for depression, suicidal ideation or other psychiatric disorder within the past 12 months. Life time history of psychotic disorder
- •Medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes.
- •Currently pregnant, pregnant within the past 6 months, currently breastfeeding or planning to become pregnant within the next 12 months.
- •Another member of the household (other than the participating parent) is a participant or staff member on this study.
- •Participation in another research study that may interfere with this study.
- •Previous participation in the SHIFT pilot study
- •Non-English speaking
- •Significant psychiatric, cognitive, developmental conditions that would impair their ability to complete assessments and/or engage in supporting the AYA with diabetes self-care behaviors (e.g., psychosis, intellectual disability)
- •Another member of the home (not AYA) is a participant/staff member on current study
- •Participation in another research study that may interfere with current study
- •Previous participation in SHIFT pilot study
研究组 & 干预措施
Group A: SHIFT2
Adolescents and young adults will engage in routine medical visits and attend 6 sessions (1x/month) focused on transition preparation and diabetes management with a transition coach and will receive bi-weekly messages during these 6-months that encourage self-management behaviors.
Parents will attend 2 sessions (month 1 and 6) with a transition coach and will receive materials, complementing their child's lesson, 1x/month for months 2-5 that focus on transition their role and supporting their child's diabetes management.
干预措施: Transition preparation program (Behavioral)
Group B: TAU+/Control
Participants will engage in routine medical visits and will receive education materials monthly (1x/month) regarding healthcare transition and diabetes management.
干预措施: Educational materials (Other)
结局指标
主要结局
Hemoglobin A1C (HbA1C)
时间窗: 6 months
HbA1C will be assessed using a standard assay from a routine blood draw or an at-home testing kit
Change in transition readiness
时间窗: Baseline to 6 months
Transition readiness will be measured using the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) scale, which will be completed by AYAs.
Attendance at clinic visits
时间窗: 6 months
Attendance at routine clinic visits will be determined from medical records and will be assessed by the number of regularly scheduled visits attended.
Change in diabetes adherence
时间窗: Baseline to 6 months
Diabetes adherence will be assessed using the Self-Care Inventory-Revised, which will be completed by both AYA and caregivers.
次要结局
- Change in diabetes support(Baseline to 12 months)
- Attendance at clinic visits(12 months)
- HbA1C(12 months)
- Diabetes-related events(12 months)
- Change in transition readiness(Baseline to 12 months)
- Change in diabetes adherence(Baseline to 12 months)
- Change in Diabetes Distress(Baseline to 12 months)
- Change in Self Efficacy(Baseline to 12 months)
- Change in Quality of Life(Baseline to 12 months)