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临床试验/NCT03135405
NCT03135405已完成不适用

Controlling Hypertension in Native American and Other Populations

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 295 人开始时间: 2017年4月11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
295
试验地点
2
主要终点
Systolic blood pressure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Pregnancy
  • Current incarceration
  • No land line or cellular phone access

研究组 & 干预措施

Usual care

No Intervention

Intervention

Experimental

干预措施: Automated messages (Behavioral)

Intervention

Experimental

干预措施: Home BP monitors (Behavioral)

Intervention

Experimental

干预措施: Care partner reminders (Behavioral)

结局指标

主要结局

Systolic blood pressure

时间窗: 12-months

Change in systolic blood pressure from baseline

次要结局

  • Visit adherence(12-months)
  • Diastolic blood pressure(12-months)
  • Medication adherence(12-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily Schroeder

Investigator

Kaiser Permanente

研究点 (2)

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