IMPROVING HEALTH BEHAVIOR AND OUTCOMES AFTER ANGIOPLASTY

描述(摘自研究人员摘要)：这项随机试验的主要目标是在接受血管成形术或冠状动脉支架手术的患者中比较两种策略在非侵入性测试中的有效性，这两种策略旨在促进行为改变和改善两年结果、无心肌梗死、中风、II-IV级心绞痛或严重缺血的存活率。将评估一种基于风险概况个性化反馈的新型行为干预是否比标准风险降低方法在降低死亡率和主要心血管疾病发病率方面更有效，标准风险降低方法被认为是避免未来发病率和死亡率风险的机会。这一新战略以净现值经济学理论为基础。共有660名完成血管成形术或支架植入的患者将被纳入研究。净现值和标准治疗组都将接受基线风险评估。在这两组人中，健康风险行为改变的潜在领域是相同的：体育活动、吸烟、饮食、血压和药物。对照组患者将接受标准的术后方法，其中将包括显示他们在14个选定的心血管危险因素方面的概况，相对于每个因素的正常标准。他们将被要求选择2-3种行为来改变，以延长他们的寿命。试验组患者将根据他们的风险状况获得他们目前的生物学年龄或“真实年龄”。他们将被要求选择2-3种行为来改变他们的生物年龄，并展示每种行为如果保持3个月和如果保持2年将对生物年龄产生的影响。在试验的维持阶段，患者将每三个月进行一次跟踪，在每次跟踪时，他们的风险因素档案将更新。净现值组将收到他们更新的生物年龄，而对照组将收到他们最新的危险因素概况。最终结果将在两年内进行评估。这项试验旨在测试净现值方法在改善血管成形术或冠状动脉支架术后的健康行为和长期结果方面的有效性。这项研究的长期目标是确定激励行为改变的净现值方法是否在改善治疗结果和提高一组高危患者的生活质量方面有效。

DESCRIPTION (adapted from investigator's abstract): The principal objective of this randomized trial is to compare the effectiveness of two strategies for motivating behavioral change and improving two-year outcomes, survival free from myocardial infarction, stroke, Class II-IV angina or severe ischemia on non-invasive testing, among patients who have undergone angioplasty or coronary artery stent procedures. The will evaluate whether a novel behavioral intervention based on individualized feedback of risk profiles framed as the opportunity to reduce one's biologic age is more effective in reducing mortality and major cardiovascular morbidity than the standard risk reduction approach, which is framed as the opportunity to avoid future risk of morbidity and mortality. This new strategy is based on the economic theory of net-present value. A total of 660 patients who have completed angioplasty or stenting will be enrolled. Both the net-present value and standard treatment groups will receive a baseline risk evaluation. In both groups the potential areas for health risk behavior change are identical: physical activity, smoking, diet, blood pressure and medications. Control group patients will receive the standard post-procedure approach, which will include being shown their profile on 14 selected cardiovascular risk factors, relative to norms on each factor. They will be asked to choose 2-3 behaviors to change to increase their life span. Experimental group patients will receive their current biological age or "real age" based on their risk profile. They will be asked to choose 2-3 behaviors to change to reduce their biological age and shown the impact each behavior would have on biological age if maintained for 3 months and if maintained for 2 years. During the trial's maintenance phase, patients will be followed every three months, and at each follow-up will have their risk factor profile updated. The net- present value group will receive their updated biological age, and the control group will receive their updated risk factor profile. Final outcomes will be evaluated at two years. This trial is designed to test the effectiveness of the net-present value approach to improving health behavior and long-term outcomes after angioplasty or coronary artery stenting. The long-term objective of this study is to determine whether a net-present value approach for motivating behavior change is effective in improving treatment outcomes, and enhancing quality of life among a group of high-risk patients.