Understanding and Optimizing Care for Young Adults With Type 1 and Type 2 Diabetes Mellitus Transitioning to the Adult Diabetes Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Visit completion rate in patients seen in the collaborative care and usual care models
研究概览
简要总结
In this study, we will determine the feasibility of an innovative care model for young adults with diabetes and compare the primary and secondary outcomes in the innovative model to those in the usual care model for adult diabetes management at Massachusetts General Hospital (MGH) Diabetes Center.
详细描述
This study is a quasi-randomized mixed methods evaluation of the implementation of an innovative collaborative care model to assess whether it is feasible and improves indicators of diabetes and mental health, while exploring themes that will inform redesign of the care model to improve healthcare delivery to young adults with diabetes transitioning to the adult care setting. We will compare primary and secondary outcomes in this model to those in the usual care model for adult diabetes management at MGH Diabetes Center. Those who agree to the research study will be asked to complete a series of three survey questionnaires over the timeframe of the study. The electronic health records (EHRs) of these patients who agree to the research study will also be examined. All patients who successfully complete all 3 survey questionnaires will be eligible for a structured interview portion of the study to explore themes that will inform care model redesign.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or type 2 diabetes mellitus
- •Between ages 18 and 30 years
- •Any duration of diabetes
- •Must self-manage diabetes
- •A new patients at the Massachusetts General Hospital (MGH) Diabetes Center at 50 Staniford Street as of September 1,
- •The patient does not have to be diagnosed with diabetes in youth or have been previously seen at MGH for Children (MGHfC) Pediatric Diabetes Clinic to be included
排除标准
- •Patients with gestational diabetes, diabetes during pregnancy, MODY, or other forms of diabetes
- •Patients with type 2 diabetes who are on no medications (diet-controlled), or metformin only unless they are within one year of diabetes onset
- •Patients with significant cognitive, physical, or mental disability requiring that their diabetes care be managed by another individual (i.e. parent, spouse, guardian, nurse, residential facility) more than 25% of the time
- •Non-English speaking
- •Patients who are pregnant
研究组 & 干预措施
Usual Care Model
Patients enrolled in this arm will receive diabetes care per usual care at the Massachusetts General Hospital (MGH) Diabetes Center.
干预措施: Usual Care Model (Other)
Diabetes Collaborative Care Model for Young Adults
Patients enrolled in this arm will receive diabetes care per the diabetes collaborative care model for young adults.
干预措施: Diabetes Collaborative Care Model for Young Adults (Other)
结局指标
主要结局
Visit completion rate in patients seen in the collaborative care and usual care models
时间窗: 12 months
Mean number of completed visits compared to scheduled visits (visit completion rate) in patients seen in the collaborative care and usual care models
Change in diabetes-related distress, measured by Problem Areas in Diabetes (PAID)
时间窗: 12 months
Problems Areas in Diabetes (PAID) is a validated screening tool for diabetes-related distress. Will measure change in PAID scores for both arms. The minimum score is 0 and maximum score is 80. The higher the score, the more severe diabetes-related distress.
次要结局
- Change in anxiety, measured by Generalized Anxiety Disorder Scale-7(GAD-7)(12 months)
- Change in Problem Areas in Diabetes (PAID) scores among those with score of 40 or higher at baseline, indicating moderate distress(12 months)
- Change in HbA1c(12 months)
- Change in disordered eating behavior, measured by Diabetes Eating Problem Survey- Revised (DEPS-R)(12 months)
- Change in mood, measured by Patient Health Questionnaire-8 (PHQ-8)(12 months)
- Change in alcohol use, measured by Alcohol Use Disorders Identification Test Consumption (AUDIT-C)(12 months)
研究者
Deborah Wexler, MD
Clinical Director MGH Diabetes Center
Massachusetts General Hospital