A Behavioral Intervention To Improve Hypertension Control In Veterans
A Behavioral Intervention to Improve Hypertension Control in Veterans
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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New York、New York、美国、10010
- VA New York Harbor Health Care System
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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)
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Stage-matched intervention
Health Education Intervention
Usual Care
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有源比较器:Health Education Intervention (HEI)
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Stage-matched intervention
Health Education Intervention
Usual Care
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无干预:Usual Care (UC)
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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 |
---|---|---|
Blood Pressure Control
大体时间:6 months
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Blood pressure Control at 6 months
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6 months
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Systolic Blood Pressure
大体时间:6 months
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Mean systolic Blood Pressure
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6 months
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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
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6 months
|
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Change in Systolic Blood Pressure From Baseline to 6 Months
大体时间:Baseline and 6 months
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Baseline and 6 months
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Change in Number of Cardio Exercise Hours From Baseline to 6 Months
大体时间:baseline and 6 months
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baseline and 6 months
|
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Change in Morisky Score From Baseline to 6 Months
大体时间:baseline and 6 months
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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
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baseline and 6 months
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Diet Stage of Change
大体时间:6 months
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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.
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6 months
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Exercise Stage of Change
大体时间:6 months
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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.
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6 months
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Medication Stage of Change
大体时间:6 months
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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.
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6 months
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合作者和调查者
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
一般刊物
- Ulmer M, Robinaugh D, Friedberg JP, Lipsitz SR, Natarajan S. Usefulness of a run-in period to reduce drop-outs in a randomized controlled trial of a behavioral intervention. Contemp Clin Trials. 2008 Sep;29(5):705-10. doi: 10.1016/j.cct.2008.04.005. Epub 2008 May 6.
- Friedberg JP, Lipsitz SR, Natarajan S. Challenges and recommendations for blinding in behavioral interventions illustrated using a case study of a behavioral intervention to lower blood pressure. Patient Educ Couns. 2010 Jan;78(1):5-11. doi: 10.1016/j.pec.2009.04.009. Epub 2009 Jun 13.
- Friedberg JP, Rodriguez MA, Watsula ME, Lin I, Wylie-Rosett J, Allegrante JP, Lipsitz SR, Natarajan S. Effectiveness of a tailored behavioral intervention to improve hypertension control: primary outcomes of a randomized controlled trial. Hypertension. 2015 Feb;65(2):440-6. doi: 10.1161/HYPERTENSIONAHA.114.03483. Epub 2014 Nov 17.
- Rodriguez MA, Wang B, Hyoung S, Friedberg J, Wylie-Rosett J, Fang Y, Allegrante JP, Lipsitz SR, Natarajan S. Sustained Benefit of Alternate Behavioral Interventions to Improve Hypertension Control: A Randomized Clinical Trial. Hypertension. 2021 Jun;77(6):1867-1876. doi: 10.1161/HYPERTENSIONAHA.120.15192. Epub 2021 May 12.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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SMI的临床试验
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Medical University of South CarolinaNational Institute of Nursing Research (NINR)完全的
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Ponce Medical School Foundation, Inc.National Institute of Mental Health (NIMH)招聘中