02315nas a2200205   4500000000100000008004100001100002000042700001600062700001600078700001600094700001300110700001500123700001700138245011100155250001500266300001100281490000700292520176400299020004602063       2011                            d1 aLindley Richard1 aCadilhac D.1 aHoffmann S.1 aKilkenny M.1 aLalor E.1 aOsborne R.1 aBatterbsy M.00aA phase II multicentered, single-blind, randomized, controlled trial of the stroke self-management program  a2011/04/16  a1673-90 v423 a<p>
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 &gt;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.
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