A Behavioral Intervention to Improve Hypertension Control in Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 533
- 试验地点
- 1
- 主要终点
- Blood Pressure Control
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •peripheral vascular disease
- •will be entered into the study if the CVD event or diagnosis occurred = 6 months ago.
排除标准
- •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
- •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.
研究组 & 干预措施
Stage-matched intervention (SMI)
Stage-matched intervention (SMI)
干预措施: HEI (Behavioral)
Stage-matched intervention (SMI)
Stage-matched intervention (SMI)
干预措施: UC (Behavioral)
Stage-matched intervention (SMI)
Stage-matched intervention (SMI)
干预措施: SMI (Behavioral)
Health Education Intervention (HEI)
Health Education Intervention (HEI)
干预措施: SMI (Behavioral)
Health Education Intervention (HEI)
Health Education Intervention (HEI)
干预措施: HEI (Behavioral)
Health Education Intervention (HEI)
Health Education Intervention (HEI)
干预措施: UC (Behavioral)
Usual Care (UC)
Usual Care (UC)
结局指标
主要结局
Blood Pressure Control
时间窗: 6 months
Blood pressure Control at 6 months
Systolic Blood Pressure
时间窗: 6 months
Mean systolic Blood Pressure
次要结局
- Change in Number of Cardio Exercise Hours From Baseline to 6 Months(baseline and 6 months)
- Change in Proportion With BP Under Control From Baseline to 6 Months(6 months)
- Change in Systolic Blood Pressure From Baseline to 6 Months(Baseline and 6 months)
- Change in Morisky Score From Baseline to 6 Months(baseline and 6 months)
- Diet Stage of Change(6 months)
- Exercise Stage of Change(6 months)
- Medication Stage of Change(6 months)
