Southeastern Diabetes Initiative Clinical Intervention (SEDI)
A Clinical Intervention to Serve High-Risk Patients in the Southeastern Diabetes Initiative and Durham Diabetes Coalition
研究概览
详细说明
Clinical care will be delivered by a multidisciplinary team including (but not limited to) an physician, nurse practitioner, dietician, pharmacist, licensed clinical social worker (LCSW), case manager, health educator and a community health worker. Care will be delivered in community settings including home visits and community based clinics. With the exception of specific surveys (listed in the Study Intervention section) all data are being collected for the purpose of delivery of standard preventive care and clinical care. The population group will include patients diagnosed with Type 2 Diabetes Mellitus in four Southern United States counties, meeting certain inclusion criteria, and deemed "high risk" as determined by a set of standard criteria or a risk algorithm run on secondary data.
The investigators plan to characterize patients diagnosed or at risk for diabetes mellitus, and allow more detailed knowledge of their health than is provided by standard public health data. The investigators will use descriptive, parametric and non-parametric statistics to describe baseline characteristics (demographics and clinical measures of disease severity) of the sample and will compare responders and dropouts on independent and dependent variables, report any significant differences, and include this in the interpretation of results.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Mississippi
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Madison、Mississippi、美国
- Mississippi Public Health Institute
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North Carolina
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Durham、North Carolina、美国
- Durham County Department of Public Health
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Kannapolis、North Carolina、美国
- Cabarrus Health Alliance
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West Virginia
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Williamson、West Virginia、美国
- Williamson Health and Wellness Center
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-
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:
- Adults >=18yrs
- Diagnosis of Type 2 diabetes
- Reside in Durham County, NC, Cabarrus County, NC, Quitman County, MS or Mingo County, WV or the neighboring areas and receive the majority of their healthcare in the four listed counties.
- Have capacity to give consent (or have a surrogate legally authorized representative or caregiver provide consent on their behalf).
- Defined as high risk by the risk algorithm or their primary care clinician.
- Referral from the primary care clinician or patient's medical home if one has been designated.
Exclusion Criteria:
- Lack capacity to make decisions and do not have a surrogate with authority to make health care decisions.
- Have a terminal illness with a life expectancy of 6 months or less
- Diagnosis of Type 1 diabetes or gestational diabetes
- Currently pregnant (confirmed via self-report and/or medical record)
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:不适用
- 介入模型:单组作业
- 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:High Risk group
Extension of Care
|
Clinical care will be delivered by a multidisciplinary team including (but not limited to) a physician, nurse practitioner, dietitian, pharmacist, licensed clinical social worker (LCSW), case manager, health educator and a community health worker in community settings including home visits and community based clinics.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Mortality
大体时间:Up to 24 months
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Up to 24 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Rate of health services utilization
大体时间:up to 24 months
|
As measured by inpatient hospital admissions and emergency department visits
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up to 24 months
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Change in Medication Adherence
大体时间:Baseline, 6, 12, 18, and 24 months
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As measured by the Morisky Medication Adherence Score
|
Baseline, 6, 12, 18, and 24 months
|
Change in HbA1c
大体时间:Baseline, 6, 12, 18, and 24 months
|
Baseline, 6, 12, 18, and 24 months
|
|
Change in blood lipids
大体时间:Baseline, 6, 12, 18, and 24 months
|
Measurements include total cholesterol, HDL, LDL, triglycerides
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Baseline, 6, 12, 18, and 24 months
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Change in blood glucose
大体时间:Baseline, 6, 12, 18, and 24 months
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Baseline, 6, 12, 18, and 24 months
|
|
Change in blood pressure
大体时间:Baseline, 6, 12, 18, and 24 months
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Baseline, 6, 12, 18, and 24 months
|
|
Incidence of micro- and macro-vascular complications
大体时间:Up to 24 months
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Includes retinopathy, neuropathy, kidney disease, cardiovascular disease
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Up to 24 months
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Change in patient-reported outcomes
大体时间:Baseline, 6, 12, 18, and 24 months
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Includes results from PHQ 2, PAM-13, PROMIS 9, and REALM-SF surveys
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Baseline, 6, 12, 18, and 24 months
|
合作者和调查者
调查人员
- 首席研究员:Robert Califf, MD、Duke Translational Medicine Institute
- 首席研究员:Bryan Batch, MD、Duke 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 (估计)
上次提交的符合 QC 标准的更新
最后验证
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.
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