跳至主要内容
临床试验/NCT04404556
NCT04404556已完成不适用

Diabetes Journey: An Intervention to Improve Adherence Barriers for Adolescents With Type 1 Diabetes

Children's Hospital Medical Center, Cincinnati4 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2020年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
195
试验地点
4
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

入选标准

  • 未提供

排除标准

  • 未提供

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

  • 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(6-month follow-up)
  • Adherence for Insulin Pump Users(6-month follow-up)
  • Adherence to Insulin Boluses(6-month follow-up)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验