title: A phase II multicentered, single-blind, randomized, controlled trial of the stroke self-management program.
abstract: OBJECTIVE
  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.
authors.affiliation: National Stroke Research Institute, Florey Neuroscience Institutes, Heidelberg Heights 3081, Victoria, Australia. cadilhac@unimelb.edu.au
authors.forename: Dominique A
authors.initials: DA
authors.lastname: Cadilhac
authors.forename: Sally
authors.initials: S
authors.lastname: Hoffmann
authors.forename: Monique
authors.initials: M
authors.lastname: Kilkenny
authors.forename: Richard
authors.initials: R
authors.lastname: Lindley
authors.forename: Erin
authors.initials: E
authors.lastname: Lalor
authors.forename: Richard H
authors.initials: RH
authors.lastname: Osborne
authors.forename: Malcolm
authors.initials: M
authors.lastname: Batterbsy
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001315:Australia; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012648:Self Care; D016037:Single-Blind Method; D059039:Standard of Care; D000071939:Stroke Rehabilitation; D016896:Treatment Outcome