Achieving Health in Emerging Adults With Diabetes (AHEAD) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 306
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c (HbA1c)
研究概览
简要总结
The goal of this study is to determine whether the Achieving Health in Emerging Adults with Diabetes (AHEAD) Program helps emerging adults with type 1 diabetes improve their blood glucose management during the transition from pediatric to adult care.
Participants will be randomized to receive Usual Care or the AHEAD Program, which provides tailored support to emerging adults to build autonomy and competence to facilitate independent diabetes management. Researchers will compare changes in glycemia and participant-reported outcomes between groups.
详细描述
Many emerging adults with type 1 diabetes find it difficult to maintain their blood glucose levels within the recommended range most of the time. This can increase their risk for serious short- and long-term diabetes-related health problems. Managing diabetes becomes especially difficult during the transition from pediatric care to adult care when emerging adults are expected to manage their condition on their own.
The Achieving Health in Emerging Adults with Diabetes (AHEAD) Program was developed to support emerging adults with their transition to independence. It focuses on helping them build autonomy and competence needed to manage their diabetes independently. The program is based on self-determination theory and best practices for supporting successful health care transition to adult care.
In this study, 306 emerging adults will be randomly assigned to either the AHEAD Program or Usual Care arms. Participants will have 6 clinic visits and complete surveys prior to their clinic visits. AHEAD participants will receive support from a team of diabetes providers who have expertise in supporting emerging adults living with diabetes every three months. Usual Care participants will continue to receive the diabetes care as they do currently every three months.
Researchers will evaluate changes in glycemia and participant-reported outcomes (e.g., diabetes distress, transition readiness). The study will also assess the cost and cost-effectiveness of AHEAD, as well as factors related to its implementation.
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
- 16 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16-19 years of age
- •Have had type 1 diabetes ≥ 12 months
- •Had a recent HbA1c ≥7.0%
- •Currently receive outpatient diabetes care at a Seattle Children's Hospital Diabetes Clinic located in Bellevue, Everett, Federal Way, or Seattle
- •Are able to complete written surveys
- •Will be able to receive clinical care in WA State for the next 2 years
排除标准
- •Have had a pilot program AHEAD clinic visit
- •Most recent Usual Care diabetes visit was with a current AHEAD provider
结局指标
主要结局
Hemoglobin A1c (HbA1c)
时间窗: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
HbA1c laboratory measurement.
次要结局
- General Health Care Transition Readiness(From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).)
- Time In Ranges(From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).)
- Diabetes Distress(From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).)
- Diabetes-Specific Health Care Transition Readiness(From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).)
- Diabetes Family Conflict(From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).)
- Relatedness(From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).)
- Autonomy Treatment Self-Regulation Questionnaire(From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).)
- Disordered eating(From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).)
- Depression(From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).)
- Generalized Anxiety(From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).)
- Social needs(From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).)
研究者
Faisal Malik
Principle Investigator
University of British Columbia