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Community-based Approaches to Treating Hypertension and Colon Cancer Prevention (MISTER-B)

2015年4月20日 更新者：Joseph E. Ravenell, MD, MS、NYU Langone Health
Black men constitute the demographic group with the greatest burden of premature death and disability from hypertension (HTN) in the United States. But while the disproportionately high rate of hypertension-related morbidity and mortality is well documented, the epidemic of colorectal cancer (CRC) among black men is comparatively under-appreciated. For example, CRC is a leading cause of cancer death in black men with a death rate 50% higher than in white men. Low rates of screening for CRC in this population contribute significantly to this problem. The purpose of this randomized controlled trial (RCT) is to evaluate the effect of a lifestyle intervention delivered through telephone-based motivational interviewing (MINT) versus a patient navigation intervention on blood pressure reduction and CRC screening.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

740

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

  • 美国
    • New York
      • New York、New York、美国、10010
        • NYU School of Medicine

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

50年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria:

  1. Participants must be age 50 years or older,
  2. Self-identify as a black or African American male,
  3. Have uncontrolled hypertension as defined by systolic blood pressure (SBP) > 135 mmHg or diastolic blood pressure (DBP) > 85 mmHg and SBP > 130 or DBP > 80 mmHg (in those with diabetes at the screening).

Exclusion Criteria:

1. Inability to comply with the study protocol (either self-selected or by indicating during screening that he could not complete all requested tasks).

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

  • 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：Motivational Interviewing
Individuals in the motivational interviewing (MINT) arm of the study will receive telephone-based lifestyle interviewing for 6-months. Counseling will be aimed at modifying diet and/or physical activity behaviors associated with decreasing blood pressure.
行为的：MINT
Motivational interviewing for lifestyle changes associated with treating hypertension
实验性的：Patient Navigation
Participants in the patient navigation arm will receive patient navigation for colonoscopy.
行为的：Patient Navigation
Patient navigation for colonoscopy.
实验性的：PLUS
Both patient navigation for colorectal cancer screening and motivational interviewing for blood pressure control
行为的：MINT
Motivational interviewing for lifestyle changes associated with treating hypertension
行为的：Patient Navigation
Patient navigation for colonoscopy.

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
Blood Pressure
大体时间：Outcome is measured at 6-month follow-up
Three blood pressure measures and the average of the three measures will be obtained at baseline and 6-month follow-up using a Welch Allyn Vital Signs automated blood pressure monitor.
Outcome is measured at 6-month follow-up
Colon Cancer Screening Behavior
大体时间：The outcome will be measured at 6-month follow-up
Whether or not the participant was screened for colon cancer between baseline and 6-month follow-up will be assessed using self-report and patient medical records.
The outcome will be measured at 6-month follow-up

次要结果测量

结果测量
措施说明
大体时间
Medication Adherence
大体时间：6-month follow-up
Medication adherence will be assessed using the 4-item Morisky Medication Adherence scale.
6-month follow-up
Physical Activity
大体时间：6-month follow-up
Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ).
6-month follow-up
Intrinsic Motivation to Exercise
大体时间：6-month Follow-up
Intrinsic motivation will be assessed using a 17-item questionnaire.
6-month Follow-up
Self-Efficacy (Exercise)
大体时间：6-month follow-up
Self-efficacy related to exercise will be measured using a 12-iten questionnaire.
6-month follow-up
Dietary Intake
大体时间：6-month follow-up
Dietary intake will be assessed using the Food Frequency Questionnaire.
6-month follow-up
Intrinsic Motivation (Diet)
大体时间：6-month follow-up
Intrinsic motivation relating to diet will be assessed using a 17-item scale.
6-month follow-up
Self-efficacy (Diet)
大体时间：6-month follow-up
Self-efficacy relating to diet will be assessed using a 10-item scale.
6-month follow-up
Facilitators and Barriers to obtaining a colonoscopy
大体时间：6-month follow-up
Facilitators and barriers to obtaining a colonoscopy will be assessed using a self-reported scale.
6-month follow-up
Behavioral Intention relating to colon cancer screening
大体时间：6-month follow-up
Behavioral intention to screen for colon cancer will be assessed using a self-reported scale.
6-month follow-up
Social Influence relating to colon cancer screening
大体时间：6-month follow-up
Social influence relating to colon cancer screening will be assessed using a self-reported questionnaire.
6-month follow-up

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。

赞助

NYU Langone Health

合作者

Wayne State University
Cornell University

调查人员

  • 首席研究员：Joseph Ravenell, MD, MS、NYU School of Medicine

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。

一般刊物

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

2010年5月1日

初级完成 (实际的)

2014年5月1日

研究完成 (实际的)

2014年5月1日

研究注册日期

首次提交

2010年3月18日

首先提交符合 QC 标准的

2010年3月23日

首次发布 (估计)

2010年3月24日

研究记录更新

最后更新发布 (估计)

2015年4月22日

上次提交的符合 QC 标准的更新

2015年4月20日

最后验证

2015年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 09-0151

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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