VA Ann Arbor Center for Clinical Management Research, Ann Arbor, MI 48105, USA.
Contemp Clin Trials. 2012 Jul;33(4):666-78. doi: 10.1016/j.cct.2012.02.010. Epub 2012 Feb 23.
Persons with bipolar disorder (BD) experience a disproportionate burden of medical comorbidity, notably cardiovascular disease (CVD), contributing to decreased function and premature mortality. We describe the design, rationale, and baseline findings for the Self-Management Addressing Heart Risk Trial (SMAHRT), a randomized controlled effectiveness trial of an intervention (Life Goals Collaborative Care; LGCC) designed to reduce CVD risk factors and improve physical and mental health outcomes in patients with BD.
Patients with BD and at least one CVD risk factor were recruited from a VA healthcare system and randomized to either LGCC or usual care (UC). LGCC participants attended four weekly, group-based self-management sessions followed by monthly individual contacts supportive of health behavior change and ongoing medical care management. In contrast, UC participants received monthly wellness newsletters. Physiological and questionnaire assessments measured changes in CVD outcomes and quality of life (QOL) over 24 months.
Out of the 180 eligible patients, 134 patients were enrolled (74%) and 118 started the study protocols. At baseline (mean age=54, 17% female, 5% African American) participants had a high burden of clinical risk with nearly 70% reporting at least three CVD risk factors including, smoking (41%) and physical inactivity (57%). Mean mental and physical HRQOL scores were 1.5 SD below SF-12 population averages.
SMAHRT participants experienced substantial CVD morbidity and risk factors, poor symptom control, and decreased QOL. LGCC is the first integrated intervention for BD designed to mitigate suboptimal health outcomes by combining behavioral medicine and care management strategies.
双相情感障碍（BD）患者患有不成比例的合并症，尤其是心血管疾病（CVD），导致功能下降和过早死亡。我们描述了自我管理应对心脏风险试验（SMAHRT）的设计、原理和基线结果，这是一项针对干预措施（生活目标协作护理；LGCC）的随机对照有效性试验，旨在降低 BD 患者的 CVD 风险因素并改善身心健康结果。
从退伍军人事务部医疗保健系统招募了至少有一个 CVD 风险因素的 BD 患者，并将他们随机分配到 LGCC 或常规护理（UC）。LGCC 参与者参加了四次每周一次的基于小组的自我管理课程，然后每月进行一次个人联系，以支持健康行为改变和持续的医疗保健管理。相比之下，UC 参与者每月收到健康生活通讯。生理和问卷调查评估了 CVD 结局和生活质量（QOL）在 24 个月内的变化。
在 180 名符合条件的患者中，有 134 名患者（74%）入组，118 名患者开始了研究方案。在基线时（平均年龄 54 岁，17%为女性，5%为非裔美国人），参与者有很高的临床风险负担，近 70%的人报告至少有三个 CVD 风险因素，包括吸烟（41%）和缺乏体育锻炼（57%）。平均心理和身体 HRQOL 评分比 SF-12 人群平均值低 1.5 个标准差。
SMAHRT 参与者经历了大量的 CVD 发病率和风险因素、症状控制不佳和 QOL 下降。LGCC 是第一个为 BD 设计的综合干预措施，旨在通过结合行为医学和护理管理策略来改善不理想的健康结果。
