The Missouri Health Literacy and Diabetes Communication Initiative
Objective: to evaluate the efficacy of the American College of Physicians Foundation (ACPF) Diabetes Guide (Living with Diabetes: An Everyday Guide for You and Your Family) to improve diabetes self-management.
Study Sites: Nine Federally-qualified health centers or safety-net clinics at three sites in Missouri. Sites are urban (St. Louis), midsize (Columbia) and rural (Kirksville). Three FQHCs or safety net clinics are located at each of the sites.
Methods Overview and Design: A randomized controlled trial will be conducted. Patients will be recruited from identified health centers. As the intervention itself is directed to the clinic and not patient, the clinics will be randomly assigned to either 1) usual care (no treatment), 2) "Carve-In" - patients receive the Diabetes Guide and clinic staff follow-up and work with patients to create and complete action plans or 3)"Carve-Out" - patients receive the Diabetes Guide and a diabetes educator in Chicago follows up and works with patients to create and complete action plans. Recruited subjects will be administered a baseline assessment, and 3-month and 1-year follow-up assessments.
Sample: The investigators will recruit a total of 1,080 patients (n=120 per clinic) anticipating 80 percent retention through both follow-up assessments (final estimated number of patients = 720). Eligibility to participate will be defined as patients 1) ages 30 and older (to better represent disease distribution), 2) English or Spanish-speaking, 3) a confirmed (by chart) diagnosis of uncontrolled diabetes (HBA1c 7.0 or more).
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Illinois
-
Chicago、Illinois、美国、60611
- Northwestern University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Uncontrolled diabetes patients (defined as HbA1c 6.0 or greater).
- 25 years or older
- English or Spanish speaking
Exclusion Criteria:
- Uncorrectable hearing or visual impairment
- Moderate to severe cognitive deficits
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 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:Carve-In
Patients in this arm are given the Diabetes Guide and engage in six sessions of brief counseling with a nurse or medical assistant from their clinic.
Counseling focuses on behavioral changes patients can make to improve their diabetes.
|
If in one of the intervention arms, patients will receive a Diabetes Guide (a patient-friendly guide to help patients make healthy changes to improve their diabetes).
The Diabetes Guide includes a brief counseling component, to be conducted with clinic staff (Carve-In) or an outside diabetes educator (Carve-Out).
|
实验性的:Carve-Out
Patients in this arm are given the Diabetes Guide and engage in six sessions of brief counseling over-the-phone with a diabetes health educator stationed in Chicago, IL.
Counseling focuses on behavioral changes patients can make to improve their diabetes.
|
If in one of the intervention arms, patients will receive a Diabetes Guide (a patient-friendly guide to help patients make healthy changes to improve their diabetes).
The Diabetes Guide includes a brief counseling component, to be conducted with clinic staff (Carve-In) or an outside diabetes educator (Carve-Out).
|
无干预:Control
Patients in this arm receive standard care.
They receive no Diabetes Guide or brief counseling sessions
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Diabetes knowledge
大体时间:3 months, 1 year
|
3 months, 1 year
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Change in HbA1c reading
大体时间:3 months, 1 year
|
3 months, 1 year
|
合作者和调查者
调查人员
- 首席研究员:Michael S. Wolf, PhD, MPH、Northwestern University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
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.