跳至主要内容
临床试验/NCT05229718
NCT05229718
已完成
不适用

Understanding and Optimizing Care for Young Adults With Type 1 and Type 2 Diabetes Mellitus Transitioning to the Adult Diabetes Care Setting

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 45 人2021年10月1日

概览

阶段
不适用
干预措施
Usual Care Model
疾病 / 适应症
Type 1 Diabetes
发起方
Massachusetts General Hospital
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
状态
已完成
最后更新
8天前

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.

注册库
clinicaltrials.gov
开始日期
2021年10月1日
结束日期
2026年3月30日
最后更新
8天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Deborah Wexler, MD

Clinical Director MGH Diabetes Center

Massachusetts General Hospital

入排标准

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

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

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)

研究点 (2)

Loading locations...

相似试验