Effectiveness of a Family Heart Health Intervention Trial (FIT Heart I)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 1
- 主要终点
- Mean percent reduction in low-density lipoprotein (LDL) cholesterol levels in the special intervention group versus the control group
研究概览
简要总结
The primary objective of the FIT Heart Study was to test the effectiveness of a hospital-based standardized screening and educational intervention targeted to family members of patients hospitalized with CVD, to increase adherence to CVD prevention guidelines.
详细描述
FIT Heart was a randomized controlled trial that tested a novel systems approach to increase adherence to national prevention guidelines among family members of patients hospitalized with CVD. Participants were blood relatives or cohabitants of patients hospitalized with atherosclerotic cardiovascular disease, aged 20-79 years, did not have established cardiovascular disease or diabetes, and spoke English or Spanish. Participants randomized to a special intervention group received behavioral counseling and education on diet and physical activity; personalized risk factor screening and immediate feedback; and reinforcement and follow-up throughout the year. The control group received a brief CVD prevention message in the form of a handout. All participants received standardized assessments of diet, lifestyle, and CVD risk factors at baseline and 1 year (94% follow-up). The main findings have been published showing the mean percent change in LDL-cholesterol level from baseline to 1-year improved in both groups and was not significantly different in the special intervention vs. control group (-1% vs. -2%; p=.64).
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Life expectancy of at least 5 years after study entry
- •Willing to return at Year 1 for a repeat study evaluation
- •Family member was hospitalized with acute atherosclerotic cardiovascular disease, including catheter-based procedures and coronary artery bypass grafting
- •Speaks either English or Spanish
排除标准
- •Established cardiovascular disease, diabetes, active liver disease, or long-term kidney disease
- •Life expectancy less than 5 years from study entry
- •Prescription of a special diet that is not compatible with the TLC diet
- •Participation in a clinical drug study in the 3 months before study entry
- •Pregnant or planning to become pregnant
结局指标
主要结局
Mean percent reduction in low-density lipoprotein (LDL) cholesterol levels in the special intervention group versus the control group
时间窗: Measured at Year 1
次要结局
- Mean percent change in high density lipoprotein (HDL) cholesterol levels in the special intervention group versus the control group(Measured at Year 1)
- Attainment of the Therapeutic Lifestyle Change (TLC) diet(Measured at Year 1)
- Change in lipoproteins, high sensitivity C-reactive protein (hsCRP), blood pressure, body mass index, waist circumference, Framingham risk, and diet score in the special intervention group versus the control group(Measured at Year 1)
- Cost effectiveness of the personalized educational program to reduce LDL cholesterol levels and cost per life saved(Measured at Year 1)
- Impact of hsCRP beyond traditional risk factors on attainment of prevention goals(Measured at Year 1)
研究者
Lori Mosca
Professor of Medicine, Columbia University.
Columbia University