Implementing a Diabetes Intervention in Rural and Low-Income Clinics: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Change in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The goal of this study is to evaluate a Community Health Worker (CHW) program for people living with diabetes in rural areas or locations that are remote from the research team.
The study aims to answer the following questions:
- Does the CHW program improve diabetes-related health outcomes, such as blood sugar control?
- What is the sustainability of the program?
- Is the program feasible and acceptable?
Participants will be invited to attend monthly diabetes education classes led by CHWs and receive weekly mobile health check-ins from CHWs for coaching and to help coordinate care with their clinic team.
详细描述
Background:
Type 2 diabetes disproportionately affects low-income and Hispanic populations, who face barriers such as limited literacy, poverty, and lack of insurance. Prevalence is projected to rise, worsening disparities and increasing healthcare costs. Community Health Workers (CHWs) have been shown to improve diabetes outcomes by bridging patients and healthcare systems. Tele-mentoring CHWs allows interventions to be scaled geographically, but effectiveness in real-world clinics remains to be evaluated.
Objective & Aims:
This 12-month, single-arm study implements a CHW-delivered diabetes intervention in community clinics distant from the parent research team.
Aim 1: Evaluate participant clinical outcomes (primary: HbA1c; secondary: blood pressure, cholesterol, BMI, and ADA adherence measures).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Self-identified Hispanic Ethnicity
- •Spanish-speaking
- •Type 2 diabetes diagnosis, .g., physician documented diagnosis, HbA1c at least 6.5, treatment with a glucose-lowering agent
排除标准
- •Condition known to alter HbA1c levels, e.g., recent transfusion, systemic steroids
- •Severe mental illness or cognitive impairment that would preclude participation in group activities
- •Pregnancy during the intervention period
- •Type 1 diabetes mellitus
研究组 & 干预措施
CHW-led diabetes program
干预措施: Community Health Worker-led diabetes program (Behavioral)
结局指标
主要结局
Change in Hemoglobin A1c (HbA1c)
时间窗: baseline to 12 months
Change in glycemic control measured by hemoglobin A1c (HbA1c). HbA1c values will be collected at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention HbA1c levels.
次要结局
- Change in Blood Pressure(baseline to 12 months)
- Change in Cholesterol Levels(baseline to 12 months)
- Change in Body Weight(baseline to 12 months)
- Change in Body Mass Index (BMI)(baseline to 12 months)
- Adherence to American Diabetes Association (ADA) Standards of Care(baseline to 12 months)