随机对照试验评估双相障碍患者心血管疾病风险降低：自我管理应对心脏风险试验（SMAHRT）。
Randomized controlled trial to assess reduction of cardiovascular disease risk in patients with bipolar disorder: the Self-Management Addressing Heart Risk Trial (SMAHRT).
机构信息
VA Ann Arbor Center for Clinical Management Research and National Serious Mental Illness, Treatment Resource & Evaluation Center, North Campus Research Complex, 2800 Plymouth Rd, Bldg 14, Ann Arbor, MI 48109-2800, USA.
出版信息
J Clin Psychiatry. 2013 Jul;74(7):e655-62. doi: 10.4088/JCP.12m08082.
OBJECTIVES
Persons with bipolar disorder experience a disproportionate burden of medical conditions, notably cardiovascular disease (CVD), leading to impaired functioning and premature mortality. We hypothesized that the Life Goals Collaborative Care (LGCC) intervention, compared to enhanced usual care, would reduce CVD risk factors and improve physical and mental health outcomes in US Department of Veterans Affairs patients with bipolar disorder.
METHOD
Patients with an ICD-9 diagnosis of bipolar disorder and ≥ 1 CVD risk factor (N = 118) enrolled in the Self-Management Addressing Heart Risk Trial, conducted April 2008-May 2010, were randomized to LGCC (n = 58) or enhanced usual care (n = 60). Life Goals Collaborative Care included 4 weekly self-management sessions followed by tailored contacts combining health behavior change strategies, medical care management, registry tracking, and provider guideline support. Enhanced usual care included quarterly wellness newsletters sent during a 12-month period in addition to standard treatment. Primary outcome measures included systolic and diastolic blood pressure, nonfasting total cholesterol, and physical health-related quality of life.
RESULTS
Of the 180 eligible patients identified for study participation, 134 were enrolled (74%) and 118 completed outcomes assessments (mean age = 53 years, 17% female, 5% African American). Mixed effects analyses comparing changes in 24-month outcomes among patients in LGCC (n = 57) versus enhanced usual care (n = 59) groups revealed that patients receiving LGCC had reduced systolic (β = -3.1, P = .04) and diastolic blood pressure (β = -2.1, P = .04) as well as reduced manic symptoms (β = -23.9, P = .01). Life Goals Collaborative Care had no significant impact on other primary outcomes (total cholesterol and physical health-related quality of life).
CONCLUSIONS
Life Goals Collaborative Care, compared to enhanced usual care, may lead to reduced CVD risk factors, notably through decreased blood pressure, as well as reduced manic symptoms, in patients with bipolar disorder.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT00499096.
目的
双相情感障碍患者承受着不成比例的疾病负担，特别是心血管疾病（CVD），导致其功能受损和过早死亡。我们假设，与强化常规护理相比，生活目标协作护理（LGCC）干预措施将降低美国退伍军人事务部双相情感障碍患者的 CVD 风险因素，并改善其身心健康结果。
方法
在 2008 年 4 月至 2010 年 5 月期间进行的自我管理应对心脏风险试验中，纳入了符合 ICD-9 双相情感障碍诊断且≥1 个 CVD 风险因素的患者（N=118），并将其随机分配至 LGCC（n=58）或强化常规护理组（n=60）。生活目标协作护理包括 4 周的自我管理课程，然后根据患者情况进行定制化的联系，其中包括健康行为改变策略、医疗保健管理、登记跟踪和提供者指南支持。强化常规护理包括在 12 个月期间每季度发送健康生活方式通讯，以及标准治疗。主要结局测量包括收缩压和舒张压、非空腹总胆固醇和与身体健康相关的生活质量。
结果
在确定参加研究的 180 名合格患者中，有 134 名患者（74%）入组，有 118 名患者完成了结局评估（平均年龄为 53 岁，17%为女性，5%为非裔美国人）。比较 LGCC（n=57）和强化常规护理组（n=59）患者 24 个月结局变化的混合效应分析显示，接受 LGCC 的患者收缩压（β=-3.1，P=.04）和舒张压（β=-2.1，P=.04）均降低，躁狂症状也减少（β=-23.9，P=.01）。LGCC 对其他主要结局（总胆固醇和与身体健康相关的生活质量）没有显著影响。
结论
与强化常规护理相比，生活目标协作护理可能会降低双相情感障碍患者的 CVD 风险因素，特别是通过降低血压和减少躁狂症状。
试验注册
ClinicalTrials.gov 标识符：NCT00499096。
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