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Controlling Hypertension in Native American and Other Populations

2019年5月7日 更新者:Emily Schroeder、Kaiser Permanente
The study evaluates the use of automated motivational messages, visit reminders, and medication reminders (using interactive voice response technology or text messages) to improve blood pressure control among adults with hypertension that receive their care at the First Nations Community Healthsource clinic in Albuquerque, New Mexico. Half of the participants will receive usual care, while the other half will receive the automated calls or text messages and have the option to receive home blood pressure monitors and/or designate a care partner who will also receive messages. Participants will be followed for 12 months.

研究概览

详细说明

American Indians and Alaskan Natives (AI/ANs) face pervasive health disparities in comparison to other racial and ethnic groups in the United States. Treatment of hypertension is a pillar of cardiovascular disease prevention. Hypertension is the most common chronic health condition in the U.S. Uncontrolled hypertension increases the risk of acute myocardial infarction, stroke, kidney failure, and congestive heart failure. Hypertension rates are high, levels of control are low, and disparities in care are evident in AI/AN populations.

This study will take place at First Nations Community Healthsource (FNCH) in Albuquerque, New Mexico. FNCH provides primary medical care to urban AI/AN and other socially disadvantaged residents of the Albuquerque, New Mexico area. Approximately 40% of FNCH clients are AI/AN; Diné (Navajo) is the most common tribal affiliation. Many other clients served by FNCH are undocumented immigrants. Housing insecurity and homelessness are common.

This study will use a FNCH hypertension registry to identify all clients with hypertension (regardless of race or ethnicity). From this group, the study will recruit 512 clients, and randomize the participants without stratification to receive automated messages using an interactive voice recognition and text message intervention or to continue in usual care. Consistent with the principles of pragmatic randomized clinical trials, the study has few exclusion criteria in order to maximize inclusion of clients and generalizability of findings. Potentially eligible clients will be contacted by letter and phone. Those who express interest will complete a baseline visit where they provide informed consent, complete a baseline survey, and have blood pressure measured. The participants will then be randomized either to the intervention or usual care arms. Individuals randomized to the intervention arm will receive: reminders of upcoming appointments at FNCH; requests to reschedule missed appointments; reminders to refill medications; and weekly motivational messages to encourage self-care, appointment keeping, and medication-taking for hypertension. These participants will be offered a home blood pressure monitor and trained to use it if they accept, and will be asked if they wish to nominate a care partner to also receive notices of upcoming and missed appointments. In additional to their usual visits at FNCH, all participants will complete research visits with our study coordinators at 6 and 12 months, where they will again have BP measured and complete brief surveys.

研究类型

介入性

注册 (实际的)

295

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

    • New Mexico
      • Albuquerque、New Mexico、美国、87108
        • First National Community Healthsource

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

21年 至 79年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • At least two prior visits to First Nations Community Healthsource with blood pressure measurements, with at least one visit in the 24 months prior
  • Hypertension
  • Between ages 21-79

Exclusion Criteria:

  • Another preferred site of primary care
  • Significant impairment of vision and hearing
  • Life-limiting illness
  • Renal dialysis
  • Receipt of home health care, hospice services or residence in a nursing home
  • Dementia
  • Pregnancy
  • Current incarceration
  • Homeless
  • No land line or cellular phone access

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:卫生服务研究
  • 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
实验性的:干涉
Automated motivational messages and visit and medication reminders will be provided via interactive voice response calls or text messages.
Participants will have the option of receiving home blood pressure monitors.
Participants will have the option of designating a care partner who will also receive automated reminder calls or text messages.
无干预:日常护理

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Systolic blood pressure
大体时间:12-months
Change in systolic blood pressure from baseline
12-months

次要结果测量

结果测量
措施说明
大体时间
Diastolic blood pressure
大体时间:12-months
Change in diastolic blood pressure from baseline
12-months
Medication adherence
大体时间:12-months
Self-reported medication adherence using the Voils instrument
12-months
Visit adherence
大体时间:12-months
Proportion of scheduled appointments that are kept, missed or cancelled
12-months

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。

调查人员

  • 首席研究员:Emily B Schroeder, MD, PhD、Kaiser Permanente

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4月11日

初级完成 (实际的)

2019年2月28日

研究完成 (实际的)

2019年2月28日

研究注册日期

首次提交

2017年4月27日

首先提交符合 QC 标准的

2017年4月27日

首次发布 (实际的)

2017年5月1日

研究记录更新

最后更新发布 (实际的)

2019年5月9日

上次提交的符合 QC 标准的更新

2019年5月7日

最后验证

2019年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CO-16-2400
  • 2P30DK092923 (美国 NIH 拨款/合同)
  • K23DK099237 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

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