Project IMPACT: CHW Intervention (IMPACT)
2020年5月15日 更新者：NYU Langone Health
Project IMPACT: Community Health Care Worker (CHW) Intervention
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.
研究概览
详细说明
The Goal of this study is that:
- EHR-based decision support and performance feedback interventions will be more effective in improving hypertension control for South Asian patients than standard care;
- 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.
研究类型
介入性
注册 (实际的)
305
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New York
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New York、New York、美国、10016
- New York University School of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
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.
Exclusion Criteria:
- Pregnant patients are excluded.
- No children or vulnerable subjects will be enrolled in this study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：CHW Intervention
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
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Patients randomized to Group A will be invited to attend 4 more group educational sessions on self-management immediately.CHWs will follow up with participants by phone or in person through a home or clinic visit.
At these follow-up meetings, CHWs will engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to hypertension control as identified jointly by the patient and CHW.
CHWs will also collect height, weight, and blood pressure measurements at initial and in-person follow-up visits.
The CHW will make necessary referrals to other services available in the community (i.e.
exercise classes, social services, mental health, tobacco cessation, etc.).
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安慰剂比较：Control Group
Wait-list
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4 education sessions beginning 6-12 months later.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 6 Months
大体时间：6 Months
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6 Months
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Percent of current diagnosed hypertensive patients with BP <140/90 (or BP<130/80 for patients with diabetes) at 12 months
大体时间：12 months
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12 months
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Percent of patients with HbA1c <7 (for patients with hypertension + diabetes) at 6 months
大体时间：6 months
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6 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Percent of patients with diagnosis of hypertension with a BP measure taken in the past 6 months
大体时间：6 months
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6 months
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Percent of patients without hypertension having valid BP measurement, last 12 months
大体时间：12 months
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12 months
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Percent of current hypertensive patients screened for diabetes in last year
大体时间：12 months
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12 months
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Percent of current hypertensive patients receiving counseling on BMI, diet and physical activity
大体时间：12 months
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12 months
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Percent of current diagnosed hypertensive patients referred to a nutritionist in the past year
大体时间：12 months
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12 months
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Percent of current diagnosed hypertensive patients who smoke who have been referred for smoking cessation
大体时间：12 months
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12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年3月9日
初级完成 (实际的)
2019年7月1日
研究完成 (实际的)
2019年7月1日
研究注册日期
首次提交
2017年4月13日
首先提交符合 QC 标准的
2017年5月17日
首次发布 (实际的)
2017年5月18日
研究记录更新
最后更新发布 (实际的)
2020年5月18日
上次提交的符合 QC 标准的更新
2020年5月15日
最后验证
2020年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
CHW Intervention的临床试验
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Ege Miray Topcu完全的
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Ari Johnson, MDHarvard Medical School (HMS and HSDM); University of California, San Francisco; Malaria Research... 和其他合作者完全的社区卫生工作者绩效
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University of MiamiHealth Choice Network; Center for Haitian Studies完全的
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University of FloridaNational Center for Advancing Translational Sciences (NCATS)完全的
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University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)尚未招聘