A Phase II Multicentered, Single-Blind, Randomized, Controlled Trial of the Stroke Self-Management Program
A Phase II Multicentered, Single-Blind, Randomized, Controlled Trial of the Stroke Self-Management Program
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DOI：
10.1161/strokeaha.110.601997
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发表时间：
2011-06-01
期刊：
影响因子：
8.3
通讯作者：
Batterbsy, Malcolm
中科院分区：
文献类型：
--
作者：
Cadilhac, Dominique A.;Hoffmann, Sally;Batterbsy, Malcolm
背景和目的--慢性病自我管理项目对中风幸存者的益处是不确定的，因为严重损伤的个体被排除在以前的研究之外。我们进行了第二阶段的随机对照试验，以确定是否为幸存者设计的自我管理程序（SSMP; 8周）是安全和可行的标准护理（对照）或通用的自我管理程序（通用; 6周）相比。方法中风幸存者从7南澳大利亚州医院通过一封信或间接（如，报纸）。符合条件的参与者以1：1：1的比例随机分组，每组50人。主要结局是招募、参与和参与者安全。次要结果是积极和积极的参与生活中使用的健康教育影响问卷和生活质量和情绪的特点，在6个月的程序completen.Results-Of 315人筛选，149人合格，143人随机（48 SSMP，47通用，48控制）;平均年龄为69岁（SD，11），59%是女性。两组之间的人口统计学特征相似，41%有严重的认知障碍; 57%的人接受了干预，52%的SSMP和38%的普通人完成了>50%的课程（P = 0.18）。32名参与者报告了不良事件（7例对照，12例一般，13例SSMP; P = 0.3; 34%严重）;然而，没有一个可归因于干预措施。改善情绪的潜在好处被发现。结论-SSMP是安全可行的。中风特异性计划优于通用计划的好处包括更高的参与率和完成率。鉴于中风人群的预测增长和生存率的改善趋势，有必要进行疗效试验。（中风。2011;42：1673-1679.）
Background and Purpose-The benefits of chronic disease self-management programs for stroke survivors are uncertain because individuals with severe impairments have been excluded from previous research. We undertook a phase II randomized controlled trial to determine whether a self-management program designed for survivors (SSMP; 8 weeks) was safe and feasible compared to standard care (control) or a generic self-management program (generic; 6 weeks).Methods-Stroke survivors were recruited from 7 South Australian hospitals via a letter or indirectly (eg, newspapers). Eligible participants were randomized at a 1: 1: 1 ratio of 50 per group. Primary outcomes were recruitment, participation, and participant safety. Secondary outcomes were positive and active engagement in life using the Health Education Impact Questionnaire and characteristics of quality of life and mood at 6 months from program completion.Results-Of 315 people screened, 149 were eligible and 143 were randomized (48 SSMP, 47 generic, 48 control); mean age was 69 years (SD, 11) and 59% were female. Demographic features were similar between groups and 41% had severe cognitive impairment; 57% accessed the interventions, with 52% SSMP and 38% generic completing >50% of sessions (P = 0.18). Thirty-two participants reported adverse events (7 control, 12 generic, 13 SSMP; P = 0.3; 34% severe); however, none was attributable to the interventions. Potential benefits for improved mood were found.Conclusions-SSMP was safe and feasible. Benefits of the stroke-specific program over the generic program included greater participation and completion rates. An efficacy trial is warranted given the forecast growth in the stroke population and improved survival trends. (Stroke. 2011;42:1673-1679.)