Cardiovascular Intervention Improvement Telemedicine Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 428
- 试验地点
- 2
- 主要终点
- Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)
研究概览
简要总结
Cardiovascular disease (CVD) is the leading cause of death in the United States; more than 80% of veterans have > 2 risk factors for CVD. Our study is one of the first to examine the implementation of a tailored behavioral/educational self-management intervention in primary care clinics designed to improve CVD risk. The proposed study could result in a leap forward in CVD risk management among veterans for several reasons: 1) ) This is a novel extension of our previous interventions that have demonstrated improved BP, now designed to address multiple chronic conditions contributing to CVD risk, particularly hyperlipidemia and diabetes. The study focuses on both multiple CVD-related risk factor management and medication management 2) The intervention is multi-behavioral; it addresses patients' various health behavior (e.g., smoking, diet, and medication adherence). 3) Components of the intervention will include specific recommendations and transportability of intervention application software and tracking packages that will allow clinic managers to implement the intervention if it is effective.
详细描述
Anticipated Impacts on Veteran's Healthcare: Cardiovascular disease (CVD) is the leading cause of death in the U.S.; more than 80% of veterans have > 2 risk factors for CVD. An intervention that addresses multiple CVD risk factors among high-risk veterans has the greatest potential to improve morbidity and mortality.
Project Background/Rationale: The proposed study will take place in two VA primary care clinics (1-Community-Based Outpatient Clinics and 1-primary care clinic affiliated with a hospital). We will improve CVD risk among veterans by addressing the modifiable risk factors of systolic blood pressure (SBP), smoking, and low-density lipoprotein cholesterol (LDL-C). The intervention will be tailored to the needs of vulnerable high risk patients (e.g. African Americans, low literate) and integrated into clinics, thereby enhancing the potential for benefit and generalizability to other settings.
The proposed study could significantly improve CVD risk management among veterans for several reasons: 1) This intervention is a novel extension of our previous efficacious interventions, but provides a novel extension to address multiple chronic conditions contributing to CVD risk. 2) The intervention focuses on both multiple CVD-related behaviors and medication management. 3) The intervention was developed to ensure implementation across a large and representative sample of veterans; and; 4) The intervention, if found efficacious and financially self-sustaining, could be widely implemented within the VA healthcare system.
Project Objectives: The proposed study will examine two research questions:
- Can patients randomized to a clinical pharmacist-administered telephone behavioral/ medication management intervention tailored to their needs improve CVD outcomes relative to a control group over 12 months? Primary Hypothesis: (H1) Veterans who receive the behavioral/medication intervention will have greater improvement of their CVD Risk Profile over the 12 months of follow-up as compared to the control group.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in one of three Durham Veterans Affairs Medical Center (DVAMC) Primary Care Clinics affiliated with the hospital or the Raleigh Community-Based Outpatient Clinic (CBOC) for at least one year;
- •At least one visit to a primary care physician (PCP) at the Raleigh CBOC or Durham Veterans Affairs Medical Center (VAMC) associated primary care clinics in the previous 12 months;
- •Outpatient diagnostic code for hypertension and/or hypercholesterolemia and lab values indicating either poorly controlled BP levels (>150/90 Hg) AND/OR LDL (>130mg/dl) in the previous year.
排除标准
- •diagnosed with metastatic cancer,
- •diagnosed with dementia,
- •active diagnosis of psychosis,
- •treated with dialysis,
- •most recent creatinine lab level >2.5 or no creatinine lab value within past year
- •hospitalized for a stroke, heart attack, or had surgery for blocked arteries in the past 3 months,
- •participating in another interventional trial,
- •not currently receiving care at the Durham VAMC or the Raleigh CBOC
- •resident of a nursing home,
- •hard time seeing type/printing on books, magazines articles, etc.
- •hard time hearing on the telephone
- •limited/no access to telephone
- •plans to move medical care from DVAMC or Raleigh CBOC in next 12 months
- •CVD care is currently being managed by a clinical pharmacist
- •HbA1C value in the last 90day > 10% and patient is currently not on an insulin regimen.
结局指标
主要结局
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)
时间窗: 12 months
Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point \[combination of administrative med data pull and self-report at assessment\]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.
次要结局
- HBA1C in Diabetic Patients(12 months)
- Mean Systolic Blood Pressure(12 months)
- Medication Non-adherence(12 months)
- Mean Diastolic Blood Pressure(12 months)
- Cholesterol LDL(12 months)
- Body Mass Index(12 months)