VIDA: Virtual Diabetes Group Visits Across Health Systems: Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 720
- 试验地点
- 4
- 主要终点
- A1c
研究概览
简要总结
The purpose of this project is to evaluate the effectiveness of a virtual diabetes group visits on patients with type 2 diabetes mellitus (T2DM).
详细描述
Managing diabetes can be complex and burdensome; patients must modify their diet, take medications, check their blood sugar, and visit their healthcare providers regularly. Diabetes group visits (GVs)-virtual group education and diabetes support, including goal setting-create a unique setting where patients can connect with peers and receive medical care and support. GVs can improve glycemic control and decrease healthcare utilization. GVs can provide patients with comprehensive care for their multimorbid chronic condition.
Virtual GVs provide an opportunity to adapt to the current trends of telehealth and the ability to increase reach and scalability across multiple sites. Before the model can be widely adopted, important questions about the effectiveness and implementation of the virtual diabetes GV model need to be addressed. The investigators propose to build on an established program of diabetes GVs. This proposal aims to implement the virtual GV model (VIDA: Virtual Diabetes Group Visits Across Health Systems) in two distinct health systems in the Chicago region. Access Community Health Network (ACCESS) is one of the largest federally qualified health centers (FQHCs) in the United States with 35 sites across the Chicago metropolitan area, providing care for 175,000 medically under-resourced and low-income patients each year. Advocate Health Care (ADVOCATE) is a large, integrated private not-for-profit health system that includes 26 hospitals and more than 500 ambulatory sites. The system provides care across more than 129 primary care clinics in Illinois serving over 117,000 patients. Both are community-based health systems serving low-income communities in Chicago and are network partners of the Chicago Chronic Conditions Engagement Network (C3EN).
No studies have systematically implemented virtual diabetes GVs for adults with T2DM in the real-world primary care setting or across distinct health systems. The ability to train, implement, and evaluate virtual GVs across systems with different care models provides the opportunity to learn about adaptation and the obstacles and facilitators for implementation. This proposed study will compare virtual diabetes GVs to usual care using a type I hybrid effectiveness-implementation design via a pragmatic cluster randomized trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient at a PARTICIPATING clinic (at least one visit in year prior to first GV)
- •Type 2 diabetes
- •≥ 18 years old
- •A1C>8% within 6 months prior to first GV (we will first recruit patients with A1C>9%, then if spaces still available A1C>8.5%, then if spaces still available A1C>8%)
- •At least one additional cardiovascular condition (hypertension, heart disease, stroke, hyperlipidemia, peripheral vascular disease, or BMI ≥ 30)
- •English or Spanish speaking
- •PCP assented to recruiting patient
- •Patient provides written consent
排除标准
- 未提供
研究组 & 干预措施
Virtual Group Visit Arm
These subjects will attend 6 monthly virtual group visits hosted by ACCESS or Advocate research staff.
干预措施: Virtual Group Visit (Behavioral)
Usual Care Arm
These subjects will receive usual diabetes care at ACCESS or Advocate health centers.
结局指标
主要结局
A1c
时间窗: 12 months
This is blood test that measures the percent of glucose and hemoglobin bound together.
次要结局
- Low density lipoproteins(12 months)
- Systolic blood pressure(12 months)
- Body Mass Index(12 months)