A Clinical Intervention to Serve High-Risk Patients in the Southeastern Diabetes Initiative and Durham Diabetes Coalition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 648
- 试验地点
- 4
- 主要终点
- Mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Mortality
时间窗: Up to 24 months
次要结局
- Change in blood glucose(Baseline, 6, 12, 18, and 24 months)
- Change in Medication Adherence(Baseline, 6, 12, 18, and 24 months)
- Change in HbA1c(Baseline, 6, 12, 18, and 24 months)
- Change in patient-reported outcomes(Baseline, 6, 12, 18, and 24 months)
- Rate of health services utilization(up to 24 months)
- Change in blood lipids(Baseline, 6, 12, 18, and 24 months)
- Change in blood pressure(Baseline, 6, 12, 18, and 24 months)
- Incidence of micro- and macro-vascular complications(Up to 24 months)