DiaBetter Together: A Strengths-based, Peer Mentor Transition RCT for Young Adults With Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Glycemic Control (HbA1c)
研究概览
简要总结
DiaBetter Together is a strengths-based peer support intervention delivered to young adults (age 17-25) by trained Peer Mentors (age 20-35) during the transition between pediatric and adult diabetes care. The aims of this proposed randomized controlled trial are to evaluate the impact of the intervention on glycemic control (primary), time to first adult care visit, adherence, and psychosocial outcomes (secondary) in young adults with T1D after 12 months.
详细描述
DiaBetter Together is a strengths based peer support intervention delivered to young adults (age 17-25) by trained Peer Mentors (age 20-35) during the transition between pediatric and adult diabetes care. The study aims to optimize transition in T1D by leveraging and building on young adults' diabetes strengths, self-management skills, and social supports. This intervention will maximize protective processes that can facilitate optimal transition by training Peer Mentors (experienced young adults with T1D who have successfully established care in an adult setting) to provide relevant information about successful transition, teach strengths-based skills for managing transition-related challenges, share personal transition-related experiences, encourage young adults to access their social support network, and serve as a positive role model. Delivery of these strengths-based intervention components through a Peer Mentor has potential to reduce isolation, increase access to relevant information, and facilitate engagement with self-management and T1D care. This intervention is a complement to existing systems of care for young adults with T1D for 12 months as they leave the pediatric setting.
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
- Single (Outcomes Assessor)
盲法说明
Participants will be aware of their assignment to intervention or control, as will the investigators. However, the person collecting HbA1c (primary outcome) at baseline and follow-up (12 mo) will not be aware of the participant's assignment in the intervention.
入排标准
- 年龄范围
- 17 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •has a diagnosis of type 1 diabetes of at least 1 year
- •currently receiving care at a Texas Children's Hospital Diabetes Care Center location
- •is between the ages of 17-25 years at enrollment
- •exhibits fluency in reading/speaking English
- •their endocrine provider confirmed plans to transfer to adult provider in the next 6 months
排除标准
- •serious medical, cognitive, or mental health comorbidity that would preclude ability to provide informed consent or participate in data collection or intervention
- •Peer Mentor Inclusion/Exclusion Criteria
- •Inclusion Criteria:
- •was diagnosed with type 1 diabetes before age 18
- •has a diagnosis of type 1 diabetes of at least 1 years
- •is between the ages of 20-35 at enrollment
- •has been previously treated in pediatric care and is currently treated in adult care
- •demonstrated interest and ability to effectively deliver the peer intervention &
- •exhibits fluency in reading/speaking English
- •Exclusion Criteria:
- •serious medical, cognitive, or mental health comorbidity that would preclude ability to fulfill role or complete questionnaires.
结局指标
主要结局
Glycemic Control (HbA1c)
时间窗: Baseline through 12-Month Post-Randomization
HbA1c is the average blood glucose over 3-4 months. The American Diabetes Association recommends an HbA1c target of \<7.0%. HbA1c is collected via fingerstick/blood assay at routine diabetes visits and will be extracted from the medical record at each clinic visit during the study period. At Baseline and 12 months, HbA1c will be collected using the following methods: 1. Collection of most recent HbA1c from review of electronic medical chart (Texas Children's or Baylor College of Medicine) or medical records from outside provider (obtained with written permission from participant). 2. A dried blood spot at-home Hemoglobin A1c kit (Whatman 903 card, BD Microtainer HI-Flow Contact-Activated Lancet) will be mailed to the participant to complete and return to the study team for analysis on the Vitros 4600 HbA1c assay (correlated with the DCA 2000). Collected for young adult participants in both arms. Peer mentors self-reported HbA1c at baseline only.
Glycemic Control (HbA1c)
时间窗: Baseline through 12-Month Post-Randomization
HbA1c is the average blood glucose over 3-4 months. The American Diabetes Association recommends an HbA1c target of \<7.0%. HbA1c is collected via fingerstick/blood assay at routine diabetes visits and will be extracted from the medical record at each clinic visit during the study period. At Baseline and 12 months, HbA1c will be collected using the following methods: 1. Collection of most recent HbA1c from review of electronic medical chart (Texas Children's or Baylor College of Medicine) or medical records from outside provider (obtained with written permission from participant). 2. A dried blood spot at-home Hemoglobin A1c kit (Whatman 903 card, BD Microtainer HI-Flow Contact-Activated Lancet) will be mailed to the participant to complete and return to the study team for analysis on the Vitros 4600 HbA1c assay (correlated with the DCA 2000). Collected for young adult participants in both arms. Peer mentors self-reported HbA1c at baseline only.
次要结局
- Diabetes Distress (Diabetes Distress Scale for Adults With T1D)(Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization)
- Time to First Adult Care Visit(End of Study at 12 Months Post-Randomization)
- Diabetes Self-Management/Adherence (Self-Care Inventory-Updated)(Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization)
- Social Support (Brief 2-Way Social Support Scale)(Baseline & End of Study at 12 Months Post-Randomization)
- Transition Readiness (Readiness Assessment of Emerging Adults With Type 1 Diabetes Diagnosed in Youth)(Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization)
- General Quality of Life (Satisfaction With Life Scale)(Baseline and End of Study at 12 Months Post-Randomization)
- Health-Related Quality of Life (Type 1 Diabetes and Life)(Baseline and End of Study at 12 Months Post-Randomization)
- Diabetes Strengths (Diabetes Strengths and Resilience Measure)(Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization)
- Depressive Symptoms (PROMIS Short Form Depression 4a)(Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization)
- Emotional Support (PROMIS Short Form Emotional Support 4a)(Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization)
- Informational Support (PROMIS Short Form Informational Support 4a)(Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization)
- Social Isolation (PROMIS Short Form Social Isolation Item)(Baseline, 6-Month Post-Randomization, & End of Study at 12 Months Post-Randomization)
研究者
Marisa Hilliard
Associate Professor of Pediatrics
Baylor College of Medicine