Division of General Medicine and Clinical Epidemiology, CB 7110, University of North Carolina, Chapel Hill, NC 27599, United States; Center for Health Promotion and Disease Prevention, CB 7426, University of North Carolina, Chapel Hill, NC 27599, United States; Cecil G. Sheps Center for Health Services Research, CB 7590, University of North Carolina, Chapel Hill, NC 27599, United States.
Contemp Clin Trials. 2013 Nov;36(2):394-405. doi: 10.1016/j.cct.2013.07.013. Epub 2013 Aug 2.
Although lifestyle and medications are effective for coronary heart disease (CHD) risk reduction, few studies have examined the comparative effectiveness of various strategies for delivering high quality CHD risk reduction. In this paper, we report on the design and baseline characteristics of participants for just such a trial.
We conducted a randomized trial of the same lifestyle and medication intervention delivered in two alternate formats: counselor-delivered or web-based. The trial was conducted at 5 diverse practices in a family medicine research network and included men and women age 35-79 who were at high risk of CHD events based on 10-year predicted Framingham risk of ≥10% or a known history of cardiovascular disease. After individual-level randomization, participants in both arms received a decision aid plus four intensive intervention visits and 3 maintenance visits over 12 months. The primary outcome was change in 10-year predicted CHD risk among patients without prior cardiovascular disease. Secondary outcomes, measured among all participants, included changes in CHD risk factors, cost-effectiveness, and acceptability at 4 and 12-month follow-up.
We randomized 489 eligible patients: 389 without and 100 with a known history of cardiovascular disease. Mean age was 62.3. 75% were white, 25% African-American. 45% had a college education. 88% had health insurance. Mean 10-year predicted CHD risk was 16.9%.
We have successfully recruited a diverse sample of practices and patients that will provide a rich sample in which to test the comparative effectiveness of two strategies to implement high quality CHD prevention.
尽管生活方式和药物治疗对于降低冠心病（CHD）风险有效，但很少有研究评估各种提供高质量 CHD 风险降低策略的相对有效性。在本文中，我们报告了一项针对此类试验的参与者设计和基线特征。
我们进行了一项随机试验，对相同的生活方式和药物干预措施采用两种替代方式进行：咨询师提供或基于网络。该试验在一个家庭医学研究网络的 5 个不同实践中进行，包括基于Framingham 风险预测 10 年预测值≥10%或已知心血管疾病史的 35-79 岁男性和女性。在个体水平随机化后，两组参与者都接受了决策辅助工具，以及在 12 个月内进行 4 次强化干预访问和 3 次维持访问。主要结局是无既往心血管疾病患者的 10 年预测 CHD 风险变化。次要结局，在所有参与者中测量，包括 CHD 风险因素、成本效益和 4 个月和 12 个月随访时的可接受性变化。
我们随机化了 489 名符合条件的患者：389 名无既往心血管疾病，100 名有既往心血管疾病。平均年龄为 62.3 岁。75%为白人，25%为非裔美国人。45%有大学学历。88%有医疗保险。平均 10 年预测 CHD 风险为 16.9%。
我们已经成功招募了来自不同实践和患者的多样化样本，这将为测试两种实施高质量 CHD 预防策略的相对有效性提供丰富的样本。
