Comprehensive CVD Risk Reduction Trial in Persons with Serious Mental Illness

描述(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25年死亡。SMI中的许多过早死亡可归因于心血管疾病，与心血管疾病相关的死亡率是总人口的两倍。因此，这一由至少1500万人组成的弱势群体 美国人有很高的心血管疾病风险因素负担，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，并在2020年前将死于心血管疾病的人数减少20%。目前正在作出大量努力，以便在普通民众中实现这些目标。尽管如此，需要对患有SMI的人进行干预，他们经常有与认知障碍和精神症状有关的实质性障碍。因此，如果没有特别的努力来促进心血管健康并控制像SMI这样的脆弱人群中的风险因素，SMI患者的心血管健康不太可能得到改善，而且心血管健康的不同不仅会持续，而且可能会恶化。鉴于他们不同寻常的心血管疾病负担 考虑到风险因素，这一R-01应用的首要目标是开发和测试一种可广泛采用的可扩展干预措施，以降低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患者的心血管疾病风险。我们提出了理想的试验，一个基于社区组织的双臂临床试验，将检验一个假设 在改善SMI患者的心血管健康方面，为期18个月的全面、实用的CVD风险降低计划将优于对照组。我们将与一家大型精神卫生保健组织合作，招募250名SMI患者参加4个精神康复日间计划或邻近的精神卫生诊所。康复计划为实施心血管疾病风险降低计划提供了合适的环境，因为患者每周都要参加几天的活动，环境因素可以在现场进行。我们将提供锻炼课程的共同背景和提供的食物的健康变化。然后，参与者将被随机分配接受这种控制条件或接受心脏健康干预者为期18个月的积极理想干预，干预者将现场提供：1)个人心血管疾病风险降低行为咨询(如戒烟、饮食)；2)与初级保健提供者协调，以确保适当管理风险因素(如血压控制)；以及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。主要结果将是全球Framingham风险评分中估计的心血管疾病风险的变化；次要结果将包括心血管健康的AHA指标。要在整个人口中有意义地减少心血管疾病，将需要有针对性的干预措施，重点放在脆弱的高危群体，如患有SMI的人群。如果成功，这项试验将提供有说服力的证据，证明在SMI中使用实用、全面的心血管疾病风险降低策略来减少健康差距。 公共卫生相关性：由于严重精神疾病患者的死亡平均比普通人群早25年，心血管死亡率是普通人群的两倍，所有主要心血管风险因素的负担都非常高，因此他们迫切需要量身定制的心血管风险降低计划。我们建议在精神康复计划中进行一项随机试验，以测试一个实用的、全面的心血管风险降低计划，在该计划中，干预者将与参与者一起研究心脏健康行为，并协调风险因素的治疗和初级保健。如果成功，这项干预将是一个可以广泛传播的模范项目，应该会减少严重精神疾病患者在心血管疾病风险方面的健康差距。

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. PUBLIC HEALTH RELEVANCE: Because persons with serious mental illness die on average 25 years earlier than the general population, with twice the cardiovascular mortality rate and an extremely high burden of all major cardiovascular risk factors, they have an urgent need for tailored cardiovascular risk reduction programs. We propose a randomized trial in psychiatric rehabilitation programs to test a practical, comprehensive cardiovascular risk reduction program where an interventionist will work with participants on heart healthy behaviors and coordinate treatment of risk factors with primary care. If successful, the intervention will be a model program that could be disseminated widely and should reduce health disparities in cardiovascular disease risk in persons with serious mental illness.