Interactive Multirisk-Factor Intervention for Hypertension (HTN) Blacks
2016年6月15日 更新者:Julien Dedier、Boston Medical Center
Interactive Multirisk-Factor Intervention for HTN Blacks
The aim of this study is to assess the efficacy of Telephone-Linked_Care for Hypertension Regimen Adherence in an African American population (TLC-HTN-AA). TLC-HTN-AA is a computer-based telecommunication system that will monitor, educate and counsel African American adults with hypertension on adherence to medication, diet, and exercise. The primary hypotheses are:
- TLC-HTN-AA use will improve medication regiment adherence
- TLC-HTN-AA will improve adherence to 3 healthy diet recommendations
- TLC-HTN-AA will improve levels of regular exercise
- Patients receiving TLC-HTN-AA will be more likely to become adherent to all 3 target regiments than patients in the control group
研究概览
研究类型
介入性
注册 (实际的)
337
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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Massachusetts
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Boston、Massachusetts、美国、02118
- Medical Information Systems Unit/Boston Medical Center
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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
35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
全部
描述
Inclusion Criteria:
- a patient with a primary care provider at one of Boston Medical Center's Adult Primary Care Medical Practices or one of three HealthNet health centers participating in the study
- have a physician diagnosis of hypertension
- be African American by self-report
- be 35 years of age or older
- be prescribed at least one medication for hypertension
- have poorly controlled blood pressure
- be non-adherent to at least one hypertensive medication
- understand spoken English
- have a home telephone
Exclusion Criteria:
- patients for whom a medication, diet or exercise regiment adherence improvement or maintenance program would be inappropriate
- patients with a terminal illness
- patients with severe medical or psychiatric illness
- patients with cognitive difficulty
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: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:Automated Telephone Program
The intervention was a totally automated, computer-based, interactive telephone counseling system called Telephone- Linked-Care, designed to monitor, educate, and counsel African-American adults with hypertension and to provide summary data regularly to the patient's primary care provider.
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The intervention incorporated principles of social cognitive theory, the transtheoretical model of behavioral change, and motivational interviewing, and was tailored to the user's values.
Content was also adapted to cultural characteristics of culturally African-American adults (i.e., not Caribbean-American, Black-Hispanic, etc.).
These participants also received the same health behavior education those in the control condition received.
Participants received a 75-page resource manual that described hypertension, listed dietary recommendations, heart healthy food recipes, and local resources for exercise, and provided information to support antihypertensive medication adherence.
They received a 20-min education session based on the content of this manual, and were given a pedometer and a digital weight scale (Healthometer, model # HDR900KD01).
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安慰剂比较:Health Behavior Education
The comparator group received health education relating to the management of hypertension.
Members of this group also received standard primary medical care.
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Participants received a 75-page resource manual that described hypertension, listed dietary recommendations, heart healthy food recipes, and local resources for exercise, and provided information to support antihypertensive medication adherence.
They received a 20-min education session based on the content of this manual, and were given a pedometer and a digital weight scale (Healthometer, model # HDR900KD01).
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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 |
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1-proportion of study subjects who achieve adequate adherence (greater than or equal to 80% of doses taken) at the end of the intervention period
大体时间:8 months
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Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
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8 months
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2-consumption of more than 5 servings of fruits and vegetables a day, less than 30% of calories from fat, and less than 2400 mg of sodium a day at the end of the intervention period
大体时间:8 months
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Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
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8 months
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3-adherence to CDC-ACSM recommendations for moderate intensity physical activity at the end of the intervention period
大体时间:8 months
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Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
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8 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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1-TLC-HTN-AA use will reduce the mean blood pressure and the proportion of the treatment group having uncontrolled hypertension at the end of the intervention period
大体时间:8 months
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Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
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8 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。
调查人员
- 首席研究员:Robert Friedman, MD、Boston Medical Center
- 研究主任:Jeffrey Migneault, PhD、Boston University
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
2001年10月1日
初级完成 (实际的)
2007年8月1日
研究完成 (实际的)
2007年8月1日
研究注册日期
首次提交
2005年9月12日
首先提交符合 QC 标准的
2005年9月12日
首次发布 (估计)
2005年9月21日
研究记录更新
最后更新发布 (估计)
2016年6月16日
上次提交的符合 QC 标准的更新
2016年6月15日
最后验证
2016年6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.
Automated Telephone Program的临床试验
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University of ManchesterNational Secretariat of Science, Technology and Innovation in Panama (SENACYT)完全的
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
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The University of Hong KongSydney Children's Hospitals Network; SAHK招聘中
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Ghana Health ServicesKwame Nkrumah University of Science and Technology尚未招聘戒烟 | 减少吸烟 | 吸烟,烟草 | 吸烟行为
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Turning PointMonash University; Eastern Health; BreastScreen Victoria; Lifepool; Shades of Pink完全的