Comprehensive CVD Risk Reduction Trial in Persons with Serious Mental Illness

描述（由申请人提供）：患有严重精神疾病（SMI）的人，如精神分裂症和双相情感障碍，比没有SMI的人平均早死25年。重度精神病患者中的许多过早死亡可归因于CVD，CVD相关死亡率是总体人群的两倍。因此，这一弱势群体至少有1 500万人， 美国人，具有可改变的CVD风险因素的高负担，包括吸烟、肥胖、高血压、糖尿病和血脂异常。美国心脏协会（AHA）最近制定了雄心勃勃的战略影响目标，以改善所有美国人的心血管健康，到2020年将心血管疾病死亡率降低20%。目前正在作出重大努力，以在普通民众中实现这些目标。尽管如此，干预措施需要适应的人与SMI谁往往有实质性的障碍有关的认知障碍和精神症状。因此，如果不特别努力促进心血管健康和控制易感人群（如SMI）的风险因素，SMI患者的心血管健康不太可能改善，心血管健康的肠炎不仅会持续存在，而且可能会恶化。鉴于他们的心血管疾病负担过重 风险因素，这项R-01应用的首要目标是开发和测试一种可扩展的干预措施，可以广泛采用，以减少这一脆弱人群的风险。我们的多学科研究团队拥有设计和严格测试干预措施的专业知识，以降低普通人群和SMI患者的CVD风险。我们提出了理想试验，一个社区组织为基础的，两个手臂的临床试验，将测试的假设， 18-一个月的全面、实用的降低心血管疾病风险计划在改善SMI患者的心血管健康方面上级对照。我们将与一家大型精神卫生保健组织合作，招募250名患有重度精神分裂症的人，他们参加4个精神康复日计划或毗邻的精神卫生诊所。康复计划为实施CVD风险降低计划提供了合适的环境，因为患者每周参加几天，环境因素可以在现场进行。我们将提供一个共同的背景运动课程和健康的变化，以膳食服务。然后，参与者将被随机分配接受这种对照条件或18个月的积极IDEAL干预与心脏健康干预，谁将提供现场：1）个人CVD风险降低行为咨询（例如，对于戒烟，饮食）; 2）与初级保健提供者协调以确保风险因素的适当管理（例如，血压控制）;和3）与精神卫生工作人员和社会支持合作，鼓励和激励参与者实现目标。主要结局将是根据全球心脏病风险评分估计的CVD风险的变化;次要结局将包括CV健康的AHA指标。实现整个人群心血管疾病的有意义的减少将需要有针对性的干预措施，重点是脆弱的，高风险的群体，如那些与SMI。如果成功，这项试验将提供有说服力的证据，在SMI中使用实用，全面的CVD风险降低策略，以减少健康差异。

DESCRIPTION (provided by applicant): Persons with serious mental illness (SMI), such as schizophrenia and bipolar disorder, die on average 25 years earlier than persons without SMI. Much premature death in SMI is attributable to CVD with CVD-related mortality rates twice those of the overall population. Accordingly, this vulnerable group, comprising at least 15 million Americans, has a high burden of modifiable CVD risk factors including smoking, obesity, hypertension, diabetes, and dyslipidemia. The American Heart Association (AHA) recently set ambitious strategic Impact Goals to improve the cardiovascular health of all Americans and reduce deaths from CVD by 20 percent by 2020. Substantial efforts are underway to meet these goals in the general population. Still, interventions need to be adapted for persons with SMI who often have substantial barriers related to cognitive impairment and psychiatric symptoms. Hence, without special efforts to promote CV health and control risk factors in vulnerable populations like the SMI, it is unlikely that CV health will improve in SMI patients, and disparitis in CV health will not only persist, but likely worsen. In view of their extraordinary burden of CVD risk factors, the overarching objective of this R-01 application is to develop and test a scalable intervention that could be widely adopted to reduce risk in this vulnerable population. Our multidisciplinary research team has expertise designing and rigorously testing interventions to decrease CVD risk in the general population and in persons with SMI. We propose the IDEAL Trial, a community organization-based, two-arm clinical trial that will test the hypothesis that an 18-month comprehensive, practical CVD risk reduction program will be superior to control in improving CV health in persons with SMI. We will partner with a large mental health care organization and enroll 250 persons with SMI who attend 4 psychiatric rehabilitation day programs or adjoining mental health clinics. Rehabilitation programs provide opportune settings to implement CVD risk reduction programs because patients attend several days a week and environmental components can take place on-site. We will provide a common background of exercise classes and healthy changes to meals served. Participants will then be randomized to receive this control condition or the 18-month active IDEAL intervention with a Heart Health Interventionist, who will provide on-site: 1) individual CVD risk reduction behavioral counseling (e.g., for smoking cessation, diet); 2) coordination with primary care providers to ensure appropriate management of risk factors (e.g., blood pressure control); and 3) collaboration with mental health staff and social supports to encourage and motivate participants to reach goals. The primary outcome will be the change in estimated CVD risk from the global Framingham Risk Score; secondary outcomes will include AHA metrics for CV health. Accomplishing meaningful reductions in CVD throughout the population will require targeted interventions focusing on vulnerable, high-risk groups such as those with SMI. If successful, this trial will provide persuasive evidence for use of a practical, comprehensive CVD risk reduction strategy in SMI to reduce health disparities.