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临床试验/NCT01145742
NCT01145742已完成不适用

A Collaborative Approach to Control Hypertension in Diabetes

Albert Einstein College of Medicine2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2006年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Blood pressure

研究概览

简要总结

Many primary care patients, especially in inner-city settings, do not achieve targets for blood pressure and glycemic control. There is an urgent need to enhance treatment for those who do not reach goals within the usual clinical care system. We propose to develop a multi-component intervention grounded in the Chronic Care Model, and sustainable in resource-challenged settings. Through collaboration with home health nursing and with the use of home telemetry for feedback and intensification of therapy, we will augment usual clinical services to improve health outcomes for diabetes patients who have not been able to reach therapeutic goals. There are three specific aims. First, we will establish a feasible, practical and sustainable collaborative model between the primary care sites of our practice-based research network (NYC RING), clinical researchers at the Diabetes Research and Training Center, and The Montefiore Home Health Organization, integrating the unique expertise of each of the partners and defining the roles and responsibilities of each. Second, we will develop and refine the components of the intervention, to include training primary care providers and home health nurses to integrate the technical, psychosocial and communication processes for implementation of the intervention. Third, we will assess the feasibility of the collaborative intervention by implementing the intervention for 25 primary care patients and obtain preliminary estimates of effectiveness by comparing outcomes to 25 patients receiving usual care. Our proposal includes plans to develop feasible procedures for data collection, with qualitative and quantitative methods of assessing process and outcome measures. We will use these preliminary data to revise the intervention and prepare an R18 application to further develop and test the intervention in multiple inner-city primary care sites serving low-income diabetes patients. This proposal is for secondary prevention of diabetes complications, targeting a population known for health disparities and a high burden from this chronic disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • type 2 diabetes,
  • BP above 140/90 on two health center visits,
  • home touch tone phone

排除标准

  • dementia,
  • homelessness,
  • language other than English or Spanish

研究组 & 干预措施

self-management support and BP telemonitoring

Experimental

collaborative intervention involving home BP monitoring, home behavior change counseling to enhance self management, and intensification of treatment by primary care doctors

干预措施: home health/primary care collaboration (Behavioral)

usual care

No Intervention

usual primary care management of BP. lipids, and glucose

结局指标

主要结局

Blood pressure

时间窗: baseline and 6 months

Change in blood pressure, measured at partipants' homes, between baseline and 6 months

次要结局

  • LDL Cholesterol(baseline and 6 months)
  • Hemoglobin A1c(baseline and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diane Mckee

Prof., Dept Family and Social Medicine

Albert Einstein College of Medicine

研究点 (2)

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