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临床试验/NCT04784130
NCT04784130已完成不适用

Enhancing Diabetes and Hypertension Self-Management for Rural Appalachian Patients In Patient-Centered Medical Homes

West Virginia University2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
2
主要终点
Clinical Outcomes-A1c

研究概览

简要总结

The goal of this R34 planning project is to test the feasibility and acceptability of a 12-week modified diabetes and hypertension self-management program using trained Health Coaches.

详细描述

West Virginians have one of the highest prevalence of comorbid diabetes and hypertension in the nation that pose an enormous disease and economic burden in this medically underserved state. Self-management of these two commonly found chronic conditions are an essential component of comprehensive disease management. The goal of this R34 planning project is to test the feasibility and acceptability of a 12-week culturally-tailored, multimodal, diabetes and hypertension self-management program with a core (diet and physical activity) versus core plus (diet, physical activity and medication adherence) to an enhanced usual care (EUC) control group. Seventy-five eligible adults with comorbid diabetes and hypertension will be randomized with a 1:1:1 ratio, based on allocation sequence generated by the bio-statistician investigator in the team. The study will examine the extent to which key components (diet, physical activity, and medication adherence) contribute to the differences in clinical outcomes (HbA1c and blood pressure) between three groups using quantitative and qualitative focus groups and the RE-AIM evaluation framework. The longer term effects of the intervention will be evaluated in a subsequent R01 clinical trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English speaking adults ≥ 18 years of age;
  • co-occurring diagnosis of type 2 diabetes and hypertension
  • body mass index ≥ 25.0
  • willing to be randomized, and complete the intervention and all assessments.

排除标准

  • currently pregnant or breastfeeding
  • diagnosed with a severe mental illness
  • have any condition that requires physical activity limitations or is contraindicated for the Dietary Assessment to Stop Hypertension (DASH) diet
  • inability to complete the study protocol.

结局指标

主要结局

Clinical Outcomes-A1c

时间窗: 6 months after enrollment

Difference in A1c between baseline and end of program

Clinical outcomes-BP

时间窗: 6 months after enrollment

Difference in BP between baseline and end of program

次要结局

  • Behavioral outcome - dietary modification for fruits and vegetables; questions(6 months after enrollment)
  • Behavioral outcome - Activity log; Step count, using pedometer(6 months after enrollment)
  • Behavioral outcome - exercise; questions(6 months after enrollment)
  • Behavioral outcome - medication adherence; questions(6 months after enrollment)
  • Behavioral outcome - healthy eating plan; questions(6 months after enrollment)
  • Behavioral outcome - dietary modification for high fat foods; question(6 months after enrollment)

研究者

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

Ranjita Misra

Professor

West Virginia University

研究点 (2)

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