Northern Manhattan Diabetes Community Outreach Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- HgA1C level
研究概览
简要总结
The objective of this study is to examine the effectiveness of a community health worker intervention at helping to control diabetes among Latinos with poorly controlled Type 2 diabetes.
Hypothesis: Compared to those in Enhanced usual care group, patients randomized to the intervention will, at 12 months, have greater reductions in: (1) HgA1C; (2) low density lipoprotein (LDL); and (3) systolic and diastolic BP.
详细描述
The objective of this project is to examine the effectiveness of a community health worker (CHW) intervention at addressing glycemic control among Latinos with poorly controlled Type 2 diabetes. Our group has worked with a promising model of intervention that utilizes CHW's based at one of our major community partners. Pilot data from this program has shown clinically significant prepost test improvements in HgA1C. Using the Chronic Care Model as an overarching framework, the study design of NOCHOP is a randomized controlled trial of 360 Latinos, mostly of Caribbean descent, aged 35-70 years with HgA1C >=8.0. At a minimum, subjects in the intervention group will receive four home visits, ten group level visits and monthly phone calls by CHWs based at Alianza. The control groups will receive three separate mailings of bilingual diabetes health education materials. The primary outcome is glycemic control at 12month follow up, as measured by HgA1c. The secondary outcomes are changes in cholesterol and blood pressure (BP). We will also collect exploratory data on potential mechanisms through which our intervention resulted in hypothesized improvements including medication adherence, medication Intensification, diet and exercise. If successful, our project will make an important contribution to ongoing national and local debates about the sustainability of CHW programs. In particular, data from this study would be extremely useful for local Medicaid managed care plans who have expressed strong interests in data from rigorously designed clinical trials addressing the role of CHWs in delivering culturally appropriate and effective diabetes care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients age 35-70 years*
- •Receiving care at our clinic (2 visits with a primary care provider in the previous year)
- •Living in Northern Manhattan or Western Bronx (based on zip codes)
- •Had a hemoglobin A1C-done within the past year, with the latest value being > or = 8.0
排除标准
- •Patients whose primary care physician (PCP) believes are not appropriate candidates for participation
- •Type 1 diabetics (identified by PCP), as their care is quite distinct from that of Type II patients, and there are very few such patients in our clinic
- •Patients with diabetes diagnosed when under age 25 ("new-onset" Type I diabetes) as such patients are extremely rare in our primary care clinics
- •Patients who do not self-identify as Hispanic (Hispanics can be of any race e.g. white, black, mixed)
- •Any life-threatening or extreme medical co-morbidity, such as an active cancer diagnosis, paraplegia, or end stage cardio-pulmonary disease
- •Having a diabetes diagnosis for < 1 year, to ensure the stability of hemoglobin A1C values above 8.0
- •Planning to move out of the neighborhood during the next year
- •Planning to travel out of the neighborhood for more than three consecutive months
- •Enrollment in any other cardiovascular disease (CVD) or diabetes intervention study
结局指标
主要结局
HgA1C level
时间窗: Up to 12 months
次要结局
- Measurement of LDL(Up to 12 months)
- Measurement of systolic blood pressure(Up to 12 months)
研究者
Walter Palmas, MD, MS, FAHA
Associate Professor of Clinical Medicine
Columbia University