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

Abstract:

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.

journal_name

Stroke

journal_title

Stroke

authors

Cadilhac DA,Hoffmann S,Kilkenny M,Lindley R,Lalor E,Osborne RH,Batterbsy M

doi

10.1161/STROKEAHA.110.601997

subject

Has Abstract

pub_date

2011-06-01 00:00:00

pages

1673-9

issue

6

eissn

0039-2499

issn

1524-4628

pii

STROKEAHA.110.601997

journal_volume

42

pub_type

杂志文章,多中心研究,随机对照试验

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