A Randomized clinical trial of a psychoeducational intervention to improve outcomes in systemic lupus erythematosus
A Randomized clinical trial of a psychoeducational intervention to improve outcomes in systemic lupus erythematosus
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DOI：
10.1002/art.20279
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发表时间：
2004-06-01
影响因子：
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通讯作者：
Daltroy, LH
中科院分区：
文献类型：
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作者：
Karlson, EW;Liang, MH;Daltroy, LH
目标。在一项横断面研究中，我们先前确定了系统性红斑狼疮(SLE)不良结局的两个潜在的可改变的危险因素：自我效能感和社会支持。本研究的目标是在随机对照试验中评估一种基于理论的干预措施，以提高患者的自我效能感和伴侣支持，以管理SLES。从两个学术医学中心招募符合美国风湿病学会标准并能够识别伴侣(配偶或家庭成员)的18岁及以上SLE患者，并随机分为试验组或对照组。试验组的患者和他们的伴侣接受了旨在提高自我效能感的干预措施，夫妇们就狼疮、社会支持和解决问题进行交流，形式是与护士教育人员进行一小时的会议，然后每月进行为期6个月的电话咨询。对照组的患者和他们的伴侣接受了关注安慰剂，包括45分钟的狼疮视频演示和每月的电话通话。在基线、6个月和12个月时收集身心健康状况、疾病活动和心理社会因素的测量结果。6个月和12个月时干预对身心健康和疾病活动的影响用线性回归建模，并根据基线健康状况、疾病活动、社会人口学因素、治疗变化和心理社会因素进行调整。122例患者(及其伴侣)随机分为实验干预组和注意对照组，每组58例。参与者主要是白人，大约一半受过大学教育，这些群体根据社会人口统计因素进行了平衡。6个月时，实验组的夫妻沟通(P=0.01)和问题应对(P=0.03)得分显著高于对照组。干预结束后12个月(干预结束后6个月)，实验组的社会支持(4.4比4.1；P=0.03)、自我效能感(7.2比6.2；P=0.02)、夫妻沟通(3.5比3.1；P=0.03)、疲劳感(5.1比6.3；P=0.02)明显低于对照组。在12个月时，通过简明36问卷调查，实验组的全球心理健康状况为69分，而对照组为58分(P=0.04)。在调整基线协变量的多因素模型中，6个月时夫妻交流得分显著高于对照组(P=0.004.0 1)，12个月时自我效能感(P=0.0 5)和总体心理健康状况(P=0.0 3)得分显著高于对照组，总体身体功能得分平均提高7分，具有临床意义(P=0.2)。疲劳感均分也明显低于对照组(P=0.05)。本次干预对SLE疾病活动性无明显影响。这项基于理论的系统性红斑狼疮教育干预的随机对照试验显示，与对照组相比，试验组在夫妻沟通、自我效能和心理健康状况方面的得分显著高于对照组，而疲劳得分显著低于对照组。由于夫妻沟通和自我效能感似乎是可改变的危险因素，它们也可能成为更多弱势群体的潜在目标。
Objective. In a cross-sectional study, we previously identified 2 potentially modifiable risk factors for adverse outcomes in systemic lupus erythematosus (SLE): self-efficacy and social support. The goal of this study was to evaluate in a randomized controlled trial a theory-based intervention to improve patient self-efficacy and partner support to manage SLE.Methods. Patients with SLE ages 18 years and older who met the American College of Rheumatology criteria and were able to identify a partner (spouse or family member) were recruited from 2 academic medical centers and randomized into an experimental group or a control group. Patients in the experimental group and their partners received an intervention designed to enhance self-efficacy, couples communication about lupus, social support, and problem solving, in the form of a I-hour session with a nurse educator followed by monthly telephone counseling for 6 months. Patients in the control group and their partners received an attention placebo, including a 45-minute video presentation about lupus, and monthly telephone calls. Measures of physical and mental health status, disease activity, and psychosocial factors were collected at baseline, 6 months, and 12 months. The effect of the intervention on physical and mental health and disease activity at 6 and at 12 months was modeled with linear regression and adjusted for baseline health status, disease activity, sociodemographic factors, treatment change, and psychosocial factors.Results. One hundred twenty-two patients (plus their partners) were enrolled and randomized as follows: 64 to the experimental intervention and 58 to the attention control group. The participants were predominantly white, approximately half were college educated, and the groups were balanced for sociodemographic factors. At 6 months, significantly higher scores for couples communication (P = 0.01) and problem-focused coping (P = 0.03) were seen in the experimental group compared with the control group. At 12 months (6 months after the intervention ended), social support was higher (4.4 versus 4.1; P = 0.03), self-efficacy was higher (7.2 versus 6.2; P = 0.02), couples communication was higher (3.5 versus 3.1; P = 0.03), and fatigue was lower (5.1 versus 6.3; P = 0.02) in the experimental group compared with the control group. Global mental health status at 12 months, as measured by the Short Form 36 survey, was 69 points in the experimental group compared with 58 points in the control group (P = 0.04). In multivariate models, adjusting for baseline covariates, scores for couple communication (P = 0.01) were significantly higher at 6 months, and scores for self-efficacy (P = 0.004) and global mental health status (P = 0.03) were significantly higher at 12 months in the experimental group compared with the control group, and the mean score for global physical function was higher by 7 points, which was a clinically meaningful change (P = 0.2). The mean score for fatigue was also significantly lower in the experimental group than in the control group (P = 0.05). SLE disease activity was unchanged by this intervention.Conclusion. This randomized, controlled trial of a theory-based educational intervention in SLE demonstrated significantly higher scores for couple communication, self-efficacy, and mental health status, and lower fatigue scores in the experimental group compared with the control group. Because couple communication and self-efficacy appear to be modifiable risk factors, they may also be potential targets in more disadvantaged populations.