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 Ͼ50% of sessions (Pϭ0.18). Thirty-two participants reported adverse events (7 control, 12 generic, 13 SSMP; Pϭ0.3; 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.)Key Words: clinical trial Ⅲ chronic disease Ⅲ self-care Ⅲ self-management Ⅲ stroke M ore than 60,000 strokes occur in Australia each year and stroke is a leading cause of disease burden. 1,2 At 10 years after a first-ever stroke, the cumulative risk of a recurrent event is Ϸ43%, and the risk of being disabled or deceased is Ϸ86%. 3,4 Reduced quality of life, depression and cognitive impairment are common. 5 Stroke survivors and their families often find it difficult to manage this long-term condition given the abrupt transition from being "healthy" to having disability. The situation is exacerbated by the lack of community-based programs that may help survivors reduce the risk of recurrent events and improve quality of life.Self-management programs have emerged as a mechanism for enhancing the care offered by health services. 6 -9 Components of successful self-management programs include a focus on patients' needs, goal setting, practice of skills obtained, attention to emotional and role management, and empowering patients to work effectively with health care professionals. 10,11 Previous studies have excluded survivors with severe physical disability and cognitive impairments, and this has limited the generalizability to the broader stroke population. Recent evidence supports t...
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