Behavioral/Pharmacological Telemedicine Interventions for BP Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 591
- 试验地点
- 2
- 主要终点
- Estimated Percentage of Participants in Blood Pressure Control at Baseline
研究概览
简要总结
There are 65 million Americans and over 8.5 million veterans who have been diagnosed with hypertension; yet only 31% of all hypertensive patients have their blood pressure (BP) under effective control (less than 140/90 mm/Hg). Uncontrolled hypertension greatly increases the risk of cerebral vascular accidents, coronary artery disease, myocardial infarction, renal failure, congestive heart failure, and mortality. Despite the damaging impact of hypertension and the availability of well-defined therapies and widely accepted target values for BP, interventions to improve BP control have had limited success.
详细描述
Detailed
Description Background:
There are 65 million Americans and over 8.5 million veterans who have been diagnosed with hypertension; yet only 31% of all hypertensive patients have their blood pressure (BP) under effective control (<140/90 mm/Hg). Uncontrolled hypertension greatly increases the risk of cerebral vascular accidents, coronary artery disease, myocardial infarction, renal failure, congestive heart failure, and mortality. Despite the damaging impact of hypertension and the availability of well-defined therapies and widely accepted target values for BP, interventions to improve BP control have had limited success.
Objectives:
The study is one of the first to compare three interventions designed to improve BP control: a behavioral educational intervention, an evidence-based medication management intervention, and combined intervention for patients with poor BP control defined by home BP monitoring. The primary hypotheses are: 1) Patients who receive only the behavioral intervention will show improved rates of BP control as compared to the control group over 18 months of follow-up; 2) Patients who receive only the hypertension medication management intervention will show improved rates of BP control as compared to the control group over 18 months of follow-up; and, 3) Patients who receive the combined intervention will show higher rates of BP control as compared to all other patients over the 18 months of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of uncontrolled hypertension,
- •prescribed a medication to lower blood pressure,
- •have a regular primary care physician at Durham VA Medical Center, and
- •be a veteran. For Sustainability portion the patient must have participated in an intervention arm of primary study.
排除标准
- •Hospitalized in past 3 months for stroke,
- •heart attack,
- •surgery for blocked arteries,
- •diagnosed with metastatic cancer or treated with dialysis,
- •have a diagnosis of dementia or a hearing impairment which prevents them from being able to hear/speak on the telephone, and
- •creatinine serum lab which exceed 2.5.
结局指标
主要结局
Estimated Percentage of Participants in Blood Pressure Control at Baseline
时间窗: Baseline
When patients had multiple blood pressure readings during their baseline visit, means of their systolic and diastolic readings were used as the baseline blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \<140/90mmHg for non-diabetic patients and \< 130/80mmHg for diabetic patients
Estimated Percentage of Participants in Blood Pressure Control at 6 Months
时间窗: 6month
When patients had multiple blood pressure readings during their 6 month visit, means of their systolic and diastolic readings were used as the 6 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \<140/90mmHg for non-diabetic patients and \< 130/80mmHg for diabetic patients
Estimated Percentage of Participants in Blood Pressure Control at 12 Months
时间窗: 12 month
When patients had multiple blood pressure readings during their 12 month visit, means of their systolic and diastolic readings were used as the 12 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \<140/90mmHg for non-diabetic patients and \< 130/80mmHg for diabetic patients
Estimated Percentage of Participants in Blood Pressure Control at 18 Months
时间窗: 18 month
When patients had multiple blood pressure readings during their 18 month visit, means of their systolic and diastolic readings were used as the 18 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \<140/90mmHg for non-diabetic patients and \< 130/80mmHg for diabetic patients
Blood Pressure Averages Systolic & Diastolic
时间窗: 12-month
Blood pressure measured at 12 month. BP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model.
次要结局
未报告次要终点