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.
RCT Entities:
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.
Authors: Judith Z Goldfinger; Ian M Kronish; Kezhen Fei; Albert Graciani; Peri Rosenfeld; Kate Lorig; Carol R Horowitz Journal: Contemp Clin Trials Date: 2012-06-15 Impact factor: 2.226
Authors: Anne Forster; Lesley Brown; Jane Smith; Allan House; Peter Knapp; John J Wright; John Young Journal: Cochrane Database Syst Rev Date: 2012-11-14
Authors: Geert S A F Verheyden; Vivian Weerdesteyn; Ruth M Pickering; Dorit Kunkel; Sheila Lennon; Alexander C H Geurts; Ann Ashburn Journal: Cochrane Database Syst Rev Date: 2013-05-31
Authors: Stefania Fugazzaro; Monica Denti; Monia Allisen Accogli; Stefania Costi; Donatella Pagliacci; Simona Calugi; Enrica Cavalli; Mariangela Taricco; Roberta Bardelli Journal: Int J Environ Res Public Health Date: 2021-05-31 Impact factor: 3.390