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临床试验/NCT03159533
NCT03159533已完成不适用

Project IMPACT: Community Health Care Worker (CHW) Intervention

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 305 人开始时间: 2017年3月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
305
试验地点
1
主要终点
Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 6 Months

研究概览

简要总结

The proposed study "Project IMPACT: CHW Intervention" is part of a larger study examining the efficacy, adoption, and impact of integrated EHR-based decision-support and physician feedback interventions with community health worker (CHW)-led self-management and coaching support for South Asian patients with uncontrolled hypertension. This is a randomized control intervention utilizing community health worker (CHW)-led self-management and coaching support for South Asian patients with uncontrolled hypertension at PCP clinics in New York City.

详细描述

The Goal of this study is that:

  1. EHR-based decision support and performance feedback interventions will be more effective in improving hypertension control for South Asian patients than standard care;
  2. A combined EHR-CHW intervention will be more effective in improving hypertension control for South Asian patients compared to standard care and the EHR-based intervention

Investigators hope to implement and assess the efficacy of CHW-led coaching through promotion of team-based care and use of culturally tailored education to improve hypertension control and mitigate risk factors related to CVD among South Asian patients with uncontrolled hypertension. Study findings can provide translatable and scalable models for other limited English proficient communities.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •CHW Intervention
  • •Diagnosis of hypertension or at least two systolic blood pressure measurements of 140 mm Hg or greater, or at least two diastolic BP 90 mm Hg or greater in the past 12 months.
  • •Focus Group
  • •Any clinical patients meeting the inclusion criteria for the CHW Intervention who participated in the CHW Intervention Pilot Round.

排除标准

  • •Pregnant patients are excluded.
  • •No children or vulnerable subjects will be enrolled in this study.

研究组 & 干预措施

CHW Intervention

Active Comparator

CHW lead Sessions Session1: BP and the Cardiovascular System Session 2: Nutrition and food labels Session 3: Physical Activity and Stress Management Session 4: CVD Risk factors: cholesterol, blood sugar, & Smoking Session 5: Health Communication, Healthcare access & Review

干预措施: CHW Intervention (Behavioral)

Control Group

Placebo Comparator

Wait-list

干预措施: Wait List Control Group (Behavioral)

结局指标

主要结局

Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 6 Months

时间窗: 6 Months

Percent of patients with HbA1c <7 (for patients with hypertension + diabetes) at 6 months

时间窗: 6 months

Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 12 months

时间窗: 12 months

次要结局

  • Percent of patients with diagnosis of hypertension with a BP measure taken in the past 6 months(6 months)
  • Percent of current hypertensive patients receiving counseling on BMI, diet and physical activity(12 months)
  • Percent of patients without hypertension having valid BP measurement, last 12 months(12 months)
  • Percent of current diagnosed hypertensive patients referred to a nutritionist in the past year(12 months)
  • Percent of current diagnosed hypertensive patients who smoke who have been referred for smoking cessation(12 months)
  • Percent of current hypertensive patients screened for diabetes in last year(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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