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Southeastern Diabetes Initiative Clinical Intervention (SEDI)

2016年6月16日 更新者:Duke University

A Clinical Intervention to Serve High-Risk Patients in the Southeastern Diabetes Initiative and Durham Diabetes Coalition

The purpose of the Southeastern Diabetes Initiative Clinical Intervention is to augment existing standard of care in an effort to (1) improve population level diabetes management, health outcomes and quality of life for diagnosed and undiagnosed adults living with Type 2 Diabetes Mellitus, (2) reduce disparities in diabetes management, health outcomes and quality of life for adults living with Type 2 Diabetes Mellitus, and (3) reduce healthcare costs associated with Type 2 Diabetes Mellitus.

研究概览

地位

完全的

条件

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

介入性

注册 (实际的)

648

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

    • Mississippi
      • Madison、Mississippi、美国
        • Mississippi Public Health Institute
    • North Carolina
      • Durham、North Carolina、美国
        • Durham County Department of Public Health
      • Kannapolis、North Carolina、美国
        • Cabarrus Health Alliance
    • West Virginia
      • Williamson、West Virginia、美国
        • Williamson Health and Wellness Center

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 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

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

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: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
Up to 24 months

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
up to 24 months
Change in Medication Adherence
大体时间:Baseline, 6, 12, 18, and 24 months
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
Baseline, 6, 12, 18, and 24 months
Change in blood glucose
大体时间:Baseline, 6, 12, 18, and 24 months
Baseline, 6, 12, 18, and 24 months
Change in blood pressure
大体时间:Baseline, 6, 12, 18, and 24 months
Baseline, 6, 12, 18, and 24 months
Incidence of micro- and macro-vascular complications
大体时间:Up to 24 months
Includes retinopathy, neuropathy, kidney disease, cardiovascular disease
Up to 24 months
Change in patient-reported outcomes
大体时间:Baseline, 6, 12, 18, and 24 months
Includes results from PHQ 2, PAM-13, PROMIS 9, and REALM-SF surveys
Baseline, 6, 12, 18, and 24 months

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。

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

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

2013年4月1日

初级完成 (实际的)

2016年6月1日

研究完成 (实际的)

2016年6月1日

研究注册日期

首次提交

2013年10月16日

首先提交符合 QC 标准的

2013年10月16日

首次发布 (估计)

2013年10月18日

研究记录更新

最后更新发布 (估计)

2016年6月17日

上次提交的符合 QC 标准的更新

2016年6月16日

最后验证

2015年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • Pro00043463
  • 1C1CMS331018 (其他赠款/资助编号:Centers for Medicare and Medicaid Services)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

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.

Extension of Care的临床试验

3
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