Diabetes Journey: An Intervention to Improve Adherence Barriers for Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 2
- 主要终点
- Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale
研究概览
简要总结
The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a web-based intervention addressing adherence barriers in adolescents with T1D.
详细描述
Type 1 diabetes (T1D) treatment adherence is complex and involves glucose monitoring, counting carbohydrates, and intensive insulin delivery via injections or insulin pump in response to food intake, exercise, and illness to achieve near-normal blood glucose levels. Evidence demonstrates that adhering to T1D treatment is challenging, especially during adolescence. Non-adherence leads to suboptimal glycemic levels that severely compromise health and quality of life. Suboptimal adherence to T1D treatment regimen is common in >50% of adolescents and directly related to suboptimal glycemic control, increased risk of hospitalizations for diabetic ketoacidosis, and decreased health-related quality of life (HRQOL). The maximum benefits of current diabetes technology are limited by the knowledge, skills, adherence barriers, and non-adherence behaviors.10-14 Ultimately, adolescents have to overcome these barriers in order to benefit from technological advances. Thus, there is a clear need for behaviorally focused interventions to identify and reduce adherence barriers. The overall objective of this study is to identify adolescents with elevated adherence barriers and provide novel tailored mHealth intervention (Diabetes Journey) targeting these barriers. This study is two phases and includes a small pilot of up to 12 adolescents with type 1 diabetes (Phase 1) and a randomized controlled clinical trial (Phase 2). The randomized controlled clinical trial will examine feasibility, acceptability and preliminary efficacy of Diabetes Journey versus enhanced standard of care (control group) in approximately 256 adolescents with type 1 diabetes. Primary and secondary outcomes include adherence barriers, adherence, health-related quality of life and A1C. Satisfaction and acceptability will also be examined. Mediators and moderators will include executive functioning, diabetes distress, family conflict, depressive symptoms, fear of hypoglycemia and sleep.
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
- Single (Care Provider)
盲法说明
Outcome measures are patient-reported and thus masking will not occur at the level of participant, investigator or outcomes assessor.
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
- •T1D diagnosis >1 year
- •Adolescents with T1D ages 13-17
- •Elevations on the Barriers to Diabetes Adherence questionnaire (scores of ≥3 of 53 for the Stress/Burnout and/or Time Pressure/Planning subscales) based on their previous clinic visit scores
- •Ability to read/speak English (all measures are in English)
排除标准
- •Diagnosis of significant developmental disorders (e.g., autism spectrum disorder, moderate/severe developmental or intellectual disability)
- •Comorbid medical diagnoses (e.g., cystic fibrosis, asthma) with the exception of endocrine disorders (e.g., Celiac disease, thyroid)
- •No use of/plans to use non-insulin medication for blood glucose control
研究组 & 干预措施
Diabetes Journey
Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.
干预措施: Diabetes Journey (Behavioral)
Enhanced Standard of Care
Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.
干预措施: Enhanced Standard of Care (Behavioral)
结局指标
主要结局
Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale
时间窗: 6-month follow-up
Stress and Burnout Scale - assesses frustration and feeling burned out by diabetes and its management. Score range from 1-5, with higher scores representing greater barriers.
Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale
时间窗: 6-month follow-up
Time Pressure and Planning Subscale - assesses the time and energy it takes to plan for diabetes self-management, including carrying supplies and making management decisions. Score range from 1-5, with higher scores representing greater barriers.
Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale
时间窗: 6-month follow-up
Stress and Burnout Scale - assesses frustration and feeling burned out by diabetes and its management. Score range from 1-5, with higher scores representing greater barriers.
Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale
时间窗: 6-month follow-up
Time Pressure and Planning Subscale - assesses the time and energy it takes to plan for diabetes self-management, including carrying supplies and making management decisions. Score range from 1-5, with higher scores representing greater barriers.
次要结局
- Adherence for Continuous Glucose Monitors(6-month follow-up)
- Adherence(6-month follow-up)
- Type 1 Diabetes and Life -Youth Report(6-month follow-up)
- Hemoglobin A1C(6-month follow-up)
- Adherence for Insulin Pump Users(6-month follow-up)
- Adherence to Insulin Boluses(6-month follow-up)
- Adherence(6-month follow-up)
- Hemoglobin A1C(6-month follow-up)
- Type 1 Diabetes and Life -Youth Report(6-month follow-up)
- Adherence for Continuous Glucose Monitors(6-month follow-up)
- Adherence for Insulin Pump Users(6-month follow-up)
- Adherence to Insulin Boluses(6-month follow-up)