Comprehensive CVD Risk Reduction Trial in Persons with Serious Mental Illness

针对严重精神疾病患者的综合性 CVD 风险降低试验

• 批准号: 8528712
• 负责人: Gail L. Daumit
• 金额: $ 109.65万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-15 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8528712
• 关键词: Adherence; Adopted; American; American Heart Association; Behavior; Behavioral; Bipolar Disorder; Blood Pressure; Carbon Monoxide; Cardiovascular Diseases; Cardiovascular system; Carotenoids; Cessation of life; Clinic; Clinical Trials; Collaborations; Community Services; Cost Effectiveness Analysis; Counseling; Diabetes Mellitus; Diet; Dyslipidemias; Employee; Enrollment; Ensure; Exercise; Future; General Population; Goals; Health; Health Status; Heart; High Density Lipoproteins; Hypertension; Impaired cognition; Individual; Interdisciplinary Study; Intervention; LDL Cholesterol Lipoproteins; Lipids; Maryland; Measures; Mediator of activation protein; Mental Health; Metric; Modeling; Obesity; Outcome; Participant; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Physical Fitness; Population; Primary Health Care; Provider; Public Health; Quality of life; Randomized; Rehabilitation therapy; Research; Risk; Risk Behaviors; Risk Factors; Risk Reduction; SF-12; Schizophrenia; Serum; Site; Smoking; Social support; Stroke; Symptoms; Testing; Triglycerides; Vulnerable Populations; Walking; Weight; Weight maintenance regimen; Work; arm; base; blood pressure regulation; cardiovascular disorder risk; cardiovascular risk factor; community organizations; cost; design; diabetes control; experience; fasting plasma glucose; good diet; health care service organization; health disparity; high risk; improved; medication compliance; meetings; mortality; premature; primary outcome; programs; psychiatric rehabilitation; public health relevance; randomized trial; secondary outcome; severe mental illness; skills training; smoking cessation; successful intervention

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.

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。