Improving Diabetes Equity and Advancing Care Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Change in A1c
研究概览
简要总结
The goal of this randomized trial is to determine the optimal combination and sequence of three enhancements for a team-based care model for patients living with diabetes in Chicago. The study aim is to determine optimization of intervention components. Participants will be randomly assigned to diabetes self-management training or remote glucose monitoring. After 6 months, participants will be rerandomized to a subsequent study arm (including a CHW support program) depending on a tailoring variable of change in A1c. Researchers will compare the final 6 study arms to see which combination and sequence of enhancements produces the most improvement in A1c.
详细描述
Sinai Health System is Illinois' largest private safety-net healthcare system, serving predominantly low-income communities of color with large Medicaid-eligible populations in Chicago. In response to high diabetes rates and community calls for coordinated, multidisciplinary diabetes care, Sinai designed the Center for Diabetes and Endocrinology (the Center) which launched in 2020. The Center uses a comprehensive model with streamlined services to address the full spectrum of patient medical and non-medical needs. This study seeks to determine the appropriateness and fidelity of three intervention components of a team-based care model for patients served by the Center to define the ideal sequence for improving patient outcomes. Grounded in qualitative methodology and guided by a sequential multiple assignment randomized trial (SMART), we propose evaluating the appropriateness of novel intervention components (Aim 1); measuring fidelity of new intervention components (Aim 2); comparing the effectiveness and determine optimization of intervention components (Aim 3). We will evaluate Aim 1 via key stakeholder interviews and focus groups. We will analyze Aims 2 & 3 by conducting descriptive statistics on all variables, giving special attention to outlier values. We will also run bivariate and multivariate analyses across variables of interest and time points to determine the optimal sequence of intervention activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking
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
- •A diagnosis of type 1 or type 2 diabetes
- •18+ years of age
- •Able to provide consent
- •Identify as African American/Black or Latinx
- •most recent HbA1c > 7%,
- •Have a smartphone compatible with the Glooko application
- •Have completed at least one Center appointment (i.e. current patient)
- •Completed at least 3 months of their assigned study condition
排除标准
- •Already an active user of RGM
- •Actively working with a CHW
- •Diagnosis of gestational diabetes (without type 1 or type 2)
- •Has a Power of Attorney
- •Be suffering from Stage-V renal disease or undergoing dialysis.
- •Be suffering from a severe form of cardiovascular disease (NYHA Class III and IV)
结局指标
主要结局
Change in A1c
时间窗: Baseline (time = 0); 6 months (time = 1); 12 months (time = 2)
Change in A1c from baseline to the 12-month study end point measured at the patient level. Measure will be collected every 6 months, at a minimum. The 6-month A1c will be used to determine their study condition at the rerandomization poiont.
次要结局
- Active Usage of RGM(Data will be exported from the Glooko application monthly for the full 18 months of the trial period.)
- CHW Support Adherence(After rerandomization period (starting at 6 months post enrollment))
- DSMT Attendance(Attendance data will be collected throughout the entire study period (18 months))