Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Reduction of Non-HDL cholesterol
研究概览
简要总结
The objective of IMPACT (Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets) is to determine the best management strategy for patients undergoing cardiovascular intervention. IMPACT is a prospective randomized trial that will enroll 400 patients post-cardiovascular intervention. The study will compare different cardiovascular prevention strategies: (1) usual care, (2) cardiovascular prevention consult, and (3) cardiovascular prevention consult with a behavioral intervention program over a 6-month period. The trial hypothesis is that for patients undergoing a cardiovascular intervention, a prevention consult and behavioral intervention is superior to usual care in reducing cardiovascular risk. The primary endpoint will be non-HDL cholesterol. Secondary endpoints include other lipid values, metabolic risk, smoking cessation, physical activity, nutritional status, medication adherence and quality of life. IMPACT is scheduled to begin enrollment in the June of 2012.
详细描述
SPECIFIC AIMS
Primary aim:
The primary aim is that a targeted Cardiovascular Prevention consult will reduce non-HDL cholesterol compared to usual care at 6 months post-intervention.
Secondary aim:
The secondary aim is that a targeted Cardiovascular Prevention consult plus a behavioral intervention will reduce non-HDL cholesterol compared to usual care at 6 months post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 21 years of age or older
- •Subjects scheduled to undergo a percutaneous coronary or peripheral vascular intervention
- •Patients must have the ability to understand and the willingness to sign a written informed consent document
排除标准
- •Life expectancy less than 1-year
- •Inability to walk
研究组 & 干预措施
Usual Care
Usual care includes physician assistant and/or nurse based medical and lifestyle recommendations in consultation with cardiac catheterization attending or patient's clinical cardiologist to potentially improve the patient's medical and lifestyle regimen. Relevant educational material is routinely distributed to patients.
Prevention Consult
In addition to usual care, patients will receive a prevention consult by a prevention fellow and attending following their intervention. The consult will include guideline based medical recommendations for optimization of the patient's medical regimen targeting dyslipidemia, hypertension and diabetes. In addition, each patient will be educated on the cardiovascular disease process and given detailed lifestyle recommendations on physical activity, improved nutrition, smoking cessation and medication adherence.
干预措施: Prevention Consult (Behavioral)
Consult & Behavioral Intervention
In addition to usual care and prevention consult (as detailed above), patients will receive a full motivational intervention program by a trained motivational coach and text messages over 6 months.
干预措施: Consult & Behavioral Intervention (Behavioral)
结局指标
主要结局
Reduction of Non-HDL cholesterol
时间窗: 6 months
次要结局
- Lipids(6 months)
- Nutrition(6 months)
- Metabolic risk factors(6 months)
- Physical Activity(6 months)
- Quality of life(6 months)
- Smoking cessation(6 months)
- Optimal medical regimen(6 months)
- Cardiovascular risk(6 months)
- Cardiovascular events(5 years)
- Medication Adherence(6 months)