OBJECTIVE: There is a current need for interventions that provide information to stroke survivors in a patient-centred, interactive, personalized and flexible manner. To this purpose, a standardized but content-flexible patient education programme based on the International Classification of Functioning, Disability and Health (ICF) was developed. This study evaluated the effect of this programme on perceived self-efficacy. DESIGN: Single-blind, randomized, multi-centre controlled trial. METHODS:Stroke patients undergoing neurological rehabilitation were enrolled. Perceived self-efficacy was measured with the Liverpool Self-Efficacy Scale. Secondary outcomes were life satisfaction and self-perception of the impact of the stroke on life, measured with the WHOQOL and the Stroke Impact Scale, respectively. Data obtained at baseline, post-intervention and 6-month follow-up were analysed using multi-level models of change. RESULTS:Two hundred and thirteen patients received either theICF-based patient education (n = 110) or an attention-placebo (n = 103) control intervention. Over time, patients' self-efficacy (p < .01) and participation (p < .01) improved, while emotional functioning (p < .01) deteriorated, although no significant between-group differences were observed. Explorative analyses showed that gender, loci of control, difficulty in accessing health services after discharge and life satisfaction were significant predictors of self-efficacy. CONCLUSION: There was no significant benefit of the ICF-based patient education in comparison with an attention-placebo control group. Considering the importance of the programme for the further implementation of the ICF and the need of developing effective health education interventions for stroke, the methodology used was reviewed and an updated version proposed.
RCT Entities:
OBJECTIVE: There is a current need for interventions that provide information to stroke survivors in a patient-centred, interactive, personalized and flexible manner. To this purpose, a standardized but content-flexible patient education programme based on the International Classification of Functioning, Disability and Health (ICF) was developed. This study evaluated the effect of this programme on perceived self-efficacy. DESIGN: Single-blind, randomized, multi-centre controlled trial. METHODS:Strokepatients undergoing neurological rehabilitation were enrolled. Perceived self-efficacy was measured with the Liverpool Self-Efficacy Scale. Secondary outcomes were life satisfaction and self-perception of the impact of the stroke on life, measured with the WHOQOL and the Stroke Impact Scale, respectively. Data obtained at baseline, post-intervention and 6-month follow-up were analysed using multi-level models of change. RESULTS: Two hundred and thirteen patients received either the ICF-based patient education (n = 110) or an attention-placebo (n = 103) control intervention. Over time, patients' self-efficacy (p < .01) and participation (p < .01) improved, while emotional functioning (p < .01) deteriorated, although no significant between-group differences were observed. Explorative analyses showed that gender, loci of control, difficulty in accessing health services after discharge and life satisfaction were significant predictors of self-efficacy. CONCLUSION: There was no significant benefit of the ICF-based patient education in comparison with an attention-placebo control group. Considering the importance of the programme for the further implementation of the ICF and the need of developing effective health education interventions for stroke, the methodology used was reviewed and an updated version proposed.