此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

A Behavioral Intervention To Improve Hypertension Control In Veterans

2015年5月8日 更新者:US Department of Veterans Affairs

A Behavioral Intervention to Improve Hypertension Control in Veterans

The purpose of this study is to determine whether a stage-matched intervention (SMI) will lower BP and improve treatment adherence compared to usual care (UC) or a health education intervention (HEI) in veterans with uncontrolled BP. The study will also examine the effect of SMI on patient's health-related quality of life, satisfaction, acceptability and determine its cost-effectiveness.

研究概览

详细说明

We propose a randomized controlled trial to evaluate the effect of telephone-delivered interventions (SMI and HEI) to improve BP control.

Veterans with uncontrolled hypertension (n=533) will be randomized equally to 3 groups: 1) The SMI will use the Transtheoretical model (TTM) as the unifying framework. Veterans will receive TTM stage-matched counseling for exercise, diet, and medications via monthly counseling sessions. A social worker (SW) will assess each participant's behavior and deliver the appropriate tailored SMI based on their stage of change, decisional balance, self-efficacy and the skills model questions. 2) The HEI group receives monthly telephone calls by a SW during which they will receive education about hypertension management. 3) The UC group participates in all the in-person visits but does not receive monthly calls.

There will be an initial 6-month active intervention phase followed by a 6 month monitoring phase to assess sustainability. All participants will visit the VAMC's at baseline and at 3, 6, and 12 months. Outcomes of interest include BP; adherence (to diet, exercise and medications); quality of life; satisfaction; acceptability; cost and cost-effectiveness. Patients will be blinded to which of the intervention arms (SMI or HEI) they are in, SW's will be blinded to patient's BP and staff measuring outcomes will be blinded to study assignment. The study will be analyzed using longitudinal data analysis methods using an intention to treat strategy.

研究类型

介入性

注册 (实际的)

533

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 York
      • New York、New York、美国、10010
        • VA New York Harbor Health Care System

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 及以上 (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:

  • Patients receiving continuity of care in the outpatient clinics will be eligible. This will be operationalized as 2 visits in the previous year.
  • Adults (= 21 years) with hypertension, on antihypertensive medication for = 1 year, and who have current uncontrolled BP will be enrolled.

Patients with CVD:

  • chronic stable angina
  • unstable angina
  • uncomplicated myocardial infarction
  • coronary artery bypass surgery
  • percutaneous coronary angioplasty
  • atherectomy or stent placement
  • chronic stable angina pectoris
  • stable Class I or Class II congestive heart failure
  • stroke
  • peripheral vascular disease

will be entered into the study if the CVD event or diagnosis occurred = 6 months ago.

Exclusion Criteria:

Patients with limited life expectancy (< 1 year) due to severe co-existing non-CVD disease such as:

  • terminal illnesses such as terminal cancer
  • CVD < 6 months ago
  • Class III or IV CHF
  • severe psychiatric illness such as psychosis
  • manic depression
  • alcohol abuse (> 21 drinks/week)
  • serious chronic conditions like AIDS
  • tuberculosis
  • lupus
  • and end-stage renal failure

will be excluded.

  • Other exclusions include inability to understand English
  • Lack of a landline telephone
  • Unable to follow the study protocol
  • Recent major surgery (< 3 months)
  • Patients who are temporarily in the area and plan to move in < 1 year or will not be available for follow-up
  • Those unable to provide informed consent.
  • All patients excluded and reason for exclusion will be recorded.
  • Prior to recruitment, each patient will be informed about the study and informed consent obtained.

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:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Stage-matched intervention (SMI)
Stage-matched intervention
Health Education Intervention
Usual Care
有源比较器:Health Education Intervention (HEI)
Stage-matched intervention
Health Education Intervention
Usual Care
无干预:Usual Care (UC)

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 Control
大体时间:6 months
Blood pressure Control at 6 months
6 months
Systolic Blood Pressure
大体时间:6 months
Mean systolic Blood Pressure
6 months

次要结果测量

结果测量
措施说明
大体时间
Change in Proportion With BP Under Control From Baseline to 6 Months
大体时间:6 months
6 months
Change in Systolic Blood Pressure From Baseline to 6 Months
大体时间:Baseline and 6 months
Baseline and 6 months
Change in Number of Cardio Exercise Hours From Baseline to 6 Months
大体时间:baseline and 6 months
baseline and 6 months
Change in Morisky Score From Baseline to 6 Months
大体时间:baseline and 6 months
Morkisy medication adherence self-report questionnaire, a 4-item questionnaire scored from 0-4. A score of 4 is considered most adherent, and scores of less than 4 are defined as nonadherent
baseline and 6 months
Diet Stage of Change
大体时间:6 months
The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Patients were considered adherent to diet if they reported eating the appropriate diet for hypertension (low in salt and fat with fruits, vegetables, and low-or non-fat dairy products) at least 6 days per week.
6 months
Exercise Stage of Change
大体时间:6 months
The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Exercise adherence was defined as self-reported aerobic exercise for at least 3 days per week for at least 20 minutes each time. We used the lower threshold for exercise adherence due to our patient population with multiple comorbidities, consistent with Federal guidelines for older adults with chronic conditions.
6 months
Medication Stage of Change
大体时间:6 months
The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Medication adherence was defined as self-report of taking BP medications as prescribed for at least 6 days per week.
6 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:Sundar Natarajan, MD MSc、VA New York Harbor Health Care System

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

2006年7月1日

初级完成 (实际的)

2010年1月1日

研究完成 (实际的)

2011年9月1日

研究注册日期

首次提交

2006年2月1日

首先提交符合 QC 标准的

2006年2月1日

首次发布 (估计)

2006年2月3日

研究记录更新

最后更新发布 (估计)

2015年6月1日

上次提交的符合 QC 标准的更新

2015年5月8日

最后验证

2015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

  • IIR 04-170

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.

SMI的临床试验

3
订阅