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临床试验/NCT00850824
NCT00850824已完成不适用

Diabetes Care in American Samoa

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)2 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
268
试验地点
2
主要终点
glycosolated hemoglobin (HbA1c) levels

研究概览

简要总结

As type 2 diabetes prevalence increases in the United States, the burden of diabetes falls more on groups with greater barriers to care, such as language and cultural differences, and lower economic resources. Healthy People 2010 targeted diabetes as one of six diseases for the elimination of racial and ethnic health disparities. These disparities extend to the US Territory of American Samoa, where the proportion of adults >18 years with diabetes was 19.6% in 2002, compared to 6.4% of US adults. There have been no reported diabetes interventions in Samoans in the US. The overall purpose of this application is to translate recent advances in diabetes care into clinical practice for the American Samoan community by improving methods of health care delivery and methods of diabetes self management. We will conduct a randomized clinical trial to test the effectiveness of a community health worker (CHW) and primary-care coordinated intervention to provide outreach, education and support to 352 type 2 diabetes patients and their families in American Samoa. The CHW intervention will utilize evidence-based algorithms and protocols to prompt risk behavior interventions, communication with health care team, and visit schedule. The individual treatment action plans are also guided by the Precede-Proceed Model. The outcomes at a one-year follow-up will include glycosolated hemoglobin (HbA1c), cardiovascular disease risk factors, diet and exercise behaviors, and adherence to diabetes care guidelines. The study hypothesis is that diabetes patients in the CHW trial arm will have lower HbA1c levels, lower cardiovascular disease risk factor levels, increased exercise behaviors and healthy dietary intakes and greater adherence to diabetes care such as adherence to prescribed medications, keeping medical appointments for diabetes care and specialty referrals. The intervention builds upon best clinical practices for CHWs in diabetes care by translating effective strategies to American Samoans, while also extending prior CHW research, by using a model that is potentially replicable in other ethnic minority populations suffering the burden of diabetes.

详细描述

We will perform a clinical trial to test the effectiveness of a community health worker (CHW) and primary-care coordinated intervention to provide outreach, education and support to diabetes patients and their families. The outcomes at a one-year follow-up will include glycosolated hemoglobin (HbA1c), CVD risk factors, diet and exercise behaviors, and adherence to diabetes care guidelines. The intervention builds upon best practices to date with CHWs, by translating effective strategies to Samoans, an ethnic minority population with no prior intervention research, while also extending prior CHW research, by using a model that is potentially replicable anywhere that uses outreach strategies in the context of primary care. This application builds on the current more limited activities of CHWs at the Tafuna Family Health Center (TFHC), a primary care health center established in 1998, operated by the American Samoa Government Department of Health, and designated as a community health center by the U.S. Bureau of Primary Health Care in 2003.

We will conduct a randomized controlled trial to test the effectiveness of a CHW outreach intervention, compared to usual care (UC) in a wait-list control group. The specific aims are:

A.1. To improve control of diabetes: We hypothesize that the CHW outreach intervention group will have greater one-year reductions in glycosolated hemoglobin (HbA1c) levels compared to the UC group.

A.2. To improve cardiovascular risk factors: We hypothesize that the CHW outreach intervention group will have greater one-year reductions in systolic and diastolic blood pressure, BMI, and abdominal circumference compared to the UC Group.

A.3. To improve diet and physical activity behaviors: We hypothesize that the diabetes patients randomized to the CHW intervention will have a greater one-year increase in favorable dietary and physical activity behaviors associated with self-management of their diabetes compared to the UC group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of type 2 diabetes, age 21 years and above, resident of American Samoa receiving primary care at Tafuna Family Health Center -

排除标准

  • pregnancy, receiving kidney dialysis

结局指标

主要结局

glycosolated hemoglobin (HbA1c) levels

时间窗: one year

次要结局

  • serum lipid levels(one year)
  • abdominal circumference(one year)
  • keeping scheduled medical appointments(one year)
  • Blood pressure(one year)
  • changes in dietary intake(one year)
  • keeping specialty referral for medical exams(one year)
  • changes in exericse patterns(one year)

研究者

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

Stephen McGarvey

Professor of Epidemiology and Anthropology

Brown University

研究点 (2)

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