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
研究组 & 干预措施
Community Health Workers (CHW) treatment group
There is a 6-month intervention period immediately following recruitment. Participants enrolled in the intervention will complete 5 educational sessions and attend 2 one-on-one virtual meetings.
干预措施: Integrated CHW Intervention (Behavioral)
Control group
The control participants will complete only the first educational session. The control arm will receive usual care from their primary care physician (PCP) during the first 12 months of data collection. After 12 months they will be invited to attend remaining group sessions.
干预措施: CHW Session 1 Only (Behavioral)
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)