A phase II multicentered, single-blind, randomized, controlled trial of the stroke self-management program

Cadilhac, Dominique A., Hoffmann, Sally, Kilkenny, Monique, Lindley, Richard, Lalor, Erin, Osborne, Richard H. and Batterbsy, Malcolm 2011, A phase II multicentered, single-blind, randomized, controlled trial of the stroke self-management program, Stroke, vol. 42, no. 6, pp. 1673-1679, doi: 10.1161/STROKEAHA.110.601997.

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Title A phase II multicentered, single-blind, randomized, controlled trial of the stroke self-management program
Author(s) Cadilhac, Dominique A.
Hoffmann, Sally
Kilkenny, Monique
Lindley, Richard
Lalor, Erin
Osborne, Richard H.ORCID iD for Osborne, Richard H. orcid.org/0000-0002-9081-2699
Batterbsy, Malcolm
Journal name Stroke
Volume number 42
Issue number 6
Start page 1673
End page 1679
Total pages 7
Publisher Lippincott Williams & Wilkins
Place of publication Philadelphia, Pa.
Publication date 2011-06
ISSN 0039-2499
Keyword(s) clinical trial
chronic disease
Summary 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.
Language eng
DOI 10.1161/STROKEAHA.110.601997
Field of Research 111717 Primary Health Care
Socio Economic Objective 920205 Health Education and Promotion
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2011 American Heart Association, Inc.
Persistent URL http://hdl.handle.net/10536/DRO/DU:30040685

Document type: Journal Article
Collection: School of Health and Social Development
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Created: Tue, 06 Dec 2011, 10:31:15 EST by Jane Moschetti

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