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临床试验/NCT02136654
NCT02136654Unknown不适用

Novel Model for South Asian Treatment in Diabetes (NaMaSTe-Diabetes) Trial in Primary Care

University of British Columbia2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
2
主要终点
Change in A1C or blood pressure (systolic or diastolic blood pressure)

研究概览

简要总结

South Asians (SA) living in Canada and globally have high rates of type 2 diabetes (diabetes). Despite the burden of diabetes in this population, diabetes management remains poor. SA patients are less likely to exercise, follow a healthy diet (4), participate in exercise programs (5), and are 24% less likely to achieve glucose, blood pressure and lipid targets for diabetes than the general population (6). 55-60% of SA patients were non-adherent to their diabetes life-saving medications, compared to 30-35% non-adherence in the general population (7). This large gap in diabetes care is not surprising given language and communication barriers between primary care providers and SA patients (8-10), lack of knowledge about diabetes (8-11), preference for alternative therapies (12-14) and fundamentally different cultural beliefs on diabetes and diabetes management (15-18). Although there is some preliminary evidence that culturally tailored, chronic disease models may improve outcomes (21-24), the current evidence base is insufficient to justify the system modifications required to provide culturally tailored care across primary care settings in Canada. We propose to conduct a randomized controlled trial to assess the impact of a novel culturally tailored lifestyle and medication adherence intervention in SA patients with poorly controlled diabetes. The study is called the Novel Model for South Asian diabetes Treatment (NaMaSTe-Diabetes) trial in primary care.

详细描述

South Asians living in Canada and globally have high rates of chronic diseases including hypertension, type 2 diabetes (diabetes) and cardiac disease (1-3). Diabetes is arguably one of the most pressing chronic diseases among South Asian (SA) populations as it occurs at 50% higher rates in SA patients than the general population, develops 5-10 years earlier, and is one of the principal causes of premature heart attack and death in this group (1). Despite the burden of diabetes in this population, diabetes management remains poor. Under the current health care system, SA patients are less likely to exercise, follow a healthy diet (4), participate in exercise programs (5), and are 24% less likely to achieve glucose, blood pressure and lipid targets for diabetes than the general population (6). 55-60% of SA patients were non-adherent to their diabetes life-saving medications, compared to 30-35% non-adherence in the general population (7). This large gap in diabetes care is not surprising given language and communication barriers between primary care providers and SA patients (8-10), lack of knowledge about diabetes (8-11), preference for alternative therapies (12-14) and fundamentally different cultural beliefs on diabetes and diabetes management (15-18). Although there is some preliminary evidence that culturally tailored, chronic disease models may improve outcomes (21-24), the current evidence base is insufficient to justify the system modifications required to provide culturally tailored care across primary care settings in Canada. We propose to conduct a randomized controlled trial to assess the impact of a novel culturally tailored lifestyle and medication adherence intervention in SA patients with poorly controlled diabetes. The study is called the Novel Model for South Asian diabetes Treatment (NaMaSTe-Diabetes) trial in primary care. The study aims to recruit 600 patients with type 2 diabetes and randomize them to either a culturally tailored lifestyle and medication adherence intervention (family based, culturally tailored diabetes self management education with ongoing peer support) versus usual care on glycemic control (change in A1C level) and change in blood pressure (systolic and diastolic blood pressure) from baseline to 6 months in SA patients with poorly controlled type 2 diabetes. The NaMaSTe trial is a multi-center individual randomized controlled trial of 600 SA patients with poorly controlled diabetes (A1C ≥7%) living in British Columbia, Canada.

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
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • age >19 years of age
  • type 2 diabetes mellitus requiring at least one medication (oral hypoglycemic agent and/or insulin) to control diabetes
  • A1C ≥7% in past 1 year
  • willingness/ability to attend the Diabetes education, dietician, and peer sessions and follow up assessments
  • ability to provide informed consent
  • self identify as South Asian (from India, Pakistan, Sri Lanka, or Bangladesh) regardless of generational status or timing of immigration with ability to speak in English or Punjabi.

排除标准

  • life- limiting illness <12 months
  • physical inability to exercise
  • recurrent severe hypoglycemia or hypoglycaemic unawareness
  • family member of, or living in same household as a participant
  • pregnancy or gestational diabetes.

结局指标

主要结局

Change in A1C or blood pressure (systolic or diastolic blood pressure)

时间窗: within 6 months from baseline; 0, 3, and 6 months

次要结局

  • change in fasting lipid profile(6 months; 0 and 6 months)
  • Change in weight or waist circumference(6 months; 0, 3, and 6 months)
  • change in health status(6 months; 0, 3, and 6 months)

研究者

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

Khan

Professor

University of British Columbia

研究点 (2)

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