A Clinic-Based Case Manager Administered Telephone Intervention to Reduce Cardiovascular Disease Risk in Persons Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Ambulatory Systolic Blood Pressure
研究概览
简要总结
The purpose of the study is to assess the efficacy of a case manager/social worker administered, telephone-based educational curriculum in improving cardiovascular disease related outcomes among HIV-infected clinic patients.
详细描述
Fifty high Cardiovascular Disease Risk (CVD) risk clinic patients will be randomized 1:1 to receive either a series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum delivered over 24 weeks [intervention arm], or the educational pamphlets alone [control arm]. Anthropomorphic data, blood pressure and lipid profiles will be obtained from patients to assess the efficacy of the intervention in reducing blood pressure and serum low-density lipoprotein levels (LDL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In care at the Duke Infectious Diseases Clinic for HIV and for at least 24 months
- •On antiretroviral therapy
- •2013 American Heart Association 10-year ASCVD risk score ≥ 15%, with a diagnosis of either hypertension or hyperlipidemia
- •English literate (able to speak and read at a 6th grade level)
- •Subjects must have the capacity to give legally effective consent.
排除标准
- •Patients with prior diagnosis of acute coronary syndrome, stroke, peripheral vascular disease, and end stage renal disease
结局指标
主要结局
Change in Ambulatory Systolic Blood Pressure
时间窗: Baseline, 24 weeks, 48 weeks, 72 weeks
Change of systolic blood pressure will be assessed as an absolute continuous variable, and as a proportion or persons who achieve \>5mmHg reduction in systolic blood pressure from baseline. Reported here is the change from baseline to 72 weeks.
Number of Participants Who Achieve >5mmHg Reduction in Systolic Blood Pressure From Baseline
时间窗: Baseline, 72 weeks
Change in Non-HDL (High Density Lipoprotein Cholesterol) Levels
时间窗: Baseline, 24 weeks, 48 weeks, 72 weeks
Assessment of the absolute change in fasting calculated non-high density lipoprotein cholesterol over the study period. Reported here is the change from baseline to 72 weeks.
次要结局
- Total Change in Body Weight(Baseline, 24 weeks, 48 weeks, 72 weeks)
- Change in 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score(Baseline, 24 weeks, 48 weeks, 72 weeks)