Diabetes and Hypertension Self Management Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Clinical outcomes - A1c
研究概览
简要总结
The purpose of this R15 project is to test the feasibility and effectiveness of a 12-week diabetes and hypertension self-management program using trained health coaches.
详细描述
West Virginia has high prevalence of comorbid diabetes and hypertension. Most diabetes self-management programs are hospital or clinic based and none are tailored to address the unique needs of rural WV adults with comorbid diabetes (T2DM) and hypertension (HTN). There is a critical need for new and creative community-based, culturally appropriate self-management programs in this medically underserved state. This study will use a wait-listed randomized control trial (RCT) design, using evidence-based interventions, to improve patient self-management behaviors and health outcomes (HbA1c and BP). Eligible adults with comorbid T2DM and HTN will be randomized with a 1:1 ratio to the immediate diabetes and hypertension self-management program (DHSMP; n=35) or to 6-month wait-listed control group (N=35), based on an allocation sequence generated by the biostatistician using a randomly varying block randomization method to ensure equal distribution among treatment groups.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking adults >= 18 years of age;
- •co-occurring diagnosis of T2DM and HTN;
- •body mass index >= 25.0
- •willing to be randomized and complete 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
The difference in A1c between baseline and end of program.
Clinical outcomes - BP
时间窗: 6 months after enrollment
The difference in BP (systolic and diastolic) between baseline and end of program.
Clinical outcomes - A1c
时间窗: 6 months after enrollment
The difference in A1c between baseline and end of program.
Clinical outcomes - BP
时间窗: 6 months after enrollment
The difference in BP (systolic and diastolic) between baseline and end of program.
次要结局
- Behavioral outcome - healthy eating plan; questions(6 months after enrollment)
- Behavioral outcome - exercise; questions(6 months after enrollment)