Scaling Telehealth Models to Improve Co-morbid Diabetes and Hypertension in Immigrant Populations (Phase II)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Percent of participants achieving BP control, defined as <130/80 mmHg
研究概览
简要总结
The purpose of this study is to test the effectiveness and implementation process of a culturally and contextually tailored telehealth-based community health workers (CHW) led coaching intervention for hypertension control among South Asian patients with co-morbid Diabetes Mellitus type II (DMII) and hypertension. The primary aims are to test the effectiveness of a CHW-led telehealth intervention compared to usual care, and using Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR), examine the reach, adoption, fidelity, and maintenance of the intervention within clinical and community settings.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •identified as of South Asian ethnicity
- •at least 21 years of age
- •a diagnosis of diabetes
- •a diagnosis of hypertension
- •an uncontrolled BP reading (>130/80mmHg) in the last 6 months
排除标准
- •under the age of 21
- •Women who are pregnant
- •Type 1 diabetes or diabetes secondary to other conditions (e.g. steroid-induced, pancreatic insufficiency, or chemotherapy-induced)
- •inability to perform unsupervised physical activity
结局指标
主要结局
Percent of participants achieving BP control, defined as <130/80 mmHg
时间窗: Month 6
The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) at six months.
次要结局
- Percent of participants achieving BP control, defined as <130/80 mmHg(Month 12)
- Change from Baseline in hemoglobin A1c (HbA1c) levels at Month 6(Baseline, Month 6)
- Change from Baseline in Systolic blood pressure (SBP) at Month 6(Baseline, Month 6)
- Change from Baseline in Diastolic blood pressure (DBP) at Month 6(Baseline, Month 6)
- Change from Baseline in DBP at Month 12(Baseline, Month 12)
- Change from Baseline in HbA1c levels at Month 12(Baseline, Month 12)
- Change from Baseline in SBP at Month 12(Baseline, Month 12)
- Change from Baseline in Body mass index (BMI) at Month 6(Baseline, Month 6)
- Change from Baseline in BMI at Month 12(Baseline, Month 12)