Controlling Hyperglycemia Among Minority Population (CHAMP)
2018年1月24日 更新者：Sinai Health System
Controlling Hyperglycemia Among Minority Population (CHAMP): A Randomized Controlled Trial of Two Diabetes Interventions for Underserved Communities
The purpose of this study is to compare the efficacy of three approaches in diabetes management: (1) community health worker (CHW) education; (2) text messaging; and (3) usual hospital-based care.
The goal is to determine the most cost-effective method of diabetes management among an economically-disadvantaged, minority population.
研究概览
详细说明
The CHAMP study will test the efficacy of two interventions designed to decrease uncontrolled hyperglycemia (defined as Hemoglobin-A1C (A1C) at or above 9%) among adults with diabetes.
Patients from a safety-net hospital will be randomized into three groups: 1) a control group, 2) an intervention providing diabetes self-care text messages, or 3) an intervention using community health workers to provide diabetes education and linkage to care.
Secondary objectives include increasing diabetes knowledge, improving diabetes self-management, and increasing use of primary care (i.e., make one visit to the physician in 6 months) among the intervention participants.
A cost-effectiveness analysis will determine the most appropriate way to reduce the burden of uncontrolled diabetes.
研究类型
介入性
注册 (实际的)
272
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Illinois
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Chicago、Illinois、美国、60608
- Mount Sinai Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 64年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
*Hyperglycemia with A1C ≥9%
Exclusion Criteria:
- Lives greater than 20 miles driving distance from Mount Sinai Hospital
- Pregnant women with gestational diabetes
- Advanced end-organ complications due to diabetes that include: end-stage renal disease, stroke with paresis, Congestive Heart Failure (NYHA class III or IV), or other major end-organ complication of diabetes
- Receiving treatment for a major psychiatric disorder (i.e. schizophrenia)
- Unable to understand and give informed consent in either English or Spanish
- Currently or previously participated in a diabetes research study
- Family member currently enrolled in a diabetes research study
- Previously received diabetes care related cell phone text messages
- Unable to receive text messages 3-4 times per week
- Living in a homeless shelter or temporary housing
- Plans to travel outside of the United States for more than 3 months in next year
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Community Health Worker education
During a six-month intervention period, the CHWs will conduct six home-based visitations and provide individualized diabetes education using an intensive diabetes lifestyle curriculum called Diabetes Learning Circle (DLC), developed and used by the Sinai Diabetes Education Program.
At each visit, lasting for approximately one hour, the participants will be motivated to set SMART behavioral goals for diabetes self-management.
At each visit after the initial visit, CHWs will follow-up with each participant to check their progress on their behavioral SMART goals.
In addition, the CHWs will conduct intermittent phone calls (at least one monthly) and home visits as needed.
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Diabetes self-management education by community health workers
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实验性的：Cell phone text messaging
The participants in the text messaging group will receive weekly text messages through CareMessage.
Each participant will receive 3-4 text messages per week for 6 months.
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Diabetes self-management education through cell phone text messaging
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无干预：Control
The participants in the control group will receive education as determined by the hospital's diabetes educator, dietitian, physician, or the participant's managed care provider.
No additional education will be provided by the research team.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference in Hemoglobin A1C (CHW vs. Control)
大体时间：6 months
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To assess whether there is a statistically significant difference in HbA1C level between CHW and control groups at 6 months follow-up.
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6 months
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Difference in Hemoglobin A1C (Text Message vs. Control)
大体时间：6 months
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To assess whether there is a statistically significant difference in HbA1C level between text message and control groups at 6 months follow-up.
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage change in diabetes knowledge test scores
大体时间：6 months
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Michigan Diabetes and Research Center Knowledge test
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6 months
|
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Mean change in diabetes self-efficacy scores
大体时间：6 months
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Perceived competence in diabetes scale
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6 months
|
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Mean change in diabetes distress scores
大体时间：6 months
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Problem areas in diabetes (PAID-5) scale
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6 months
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Mean change in participants' beliefs about using insulin scores
大体时间：6 months
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Insulin treatment appraisal (ITAS) scale
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6 months
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Mean changes in diabetes self-care activities
大体时间：6 months
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Diabetes self-care activities include: diet, physical activity, self-monitoring of blood glucose, foot-care, and smoking
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6 months
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Percentage of participants who visited a physician due to a diabetes related follow-up
大体时间：6 months
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Self- reported
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6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年1月1日
初级完成 (实际的)
2017年9月1日
研究完成 (实际的)
2017年9月1日
研究注册日期
首次提交
2016年2月3日
首先提交符合 QC 标准的
2016年2月11日
首次发布 (估计)
2016年2月12日
研究记录更新
最后更新发布 (实际的)
2018年1月26日
上次提交的符合 QC 标准的更新
2018年1月24日
最后验证
2018年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.