The effects of an empowerment-based self-management intervention on empowerment level, psychological distress, and quality of life in patients with poorly controlled type 2 diabetes: A randomized controlled trial

Abstract

BackgroundThere is considerable interest in advocating empowerment in diabetes care. Health professionals, however, often fail to realize empowerment in clinical practice, especially in patients with poorly controlled type 2 diabetes. ObjectivesTo evaluate the effectiveness of an empowerment-based intervention on empowerment level, psychological distress, and quality of life among patients with poorly controlled type 2 diabetes. DesignAn analysis of secondary outcomes of a prospective multi-center, randomized, parallel, investigator-blinded controlled trial. MethodsA total of 242 adult patients with poorly controlled type 2 diabetes [Hemoglobin A1c (HbA1c)≥ 58 mmol/mol in the recent six months] were randomly allocated to either intervention (n = 121) or attentional control (n = 121) groups. The design of the intervention was based on the Empowerment Process Model. The intervention group received a 6-week empowerment-based transitional care program, with significant emphasis on establishing personally meaningful goals, facilitating collaborative partnership and shared decision-making, resolving life-disease conflicts via situational reflection. Participants in the attentional control group received two general health education classes and post-discharge social calls on top of routine care. Outcomes of interest include empowerment level, diabetes distress, and quality of life. Participants were invited to complete a set of questionnaires before randomization, one-week, and three-month post-intervention. Statistical analyses were performed using the generalized estimating equations based on the intention-to-treat principle. ResultsComparing with the attention control group, participants in the intervention group showed significant improvements on empowerment level [(β= 0.163; 95% confidence interval (CI): 0.011 to 0.316, p = 0.036) at one-week post-intervention and (β= 0.176; 95% CI: 0.020 to 0.331, p = 0.027) at three-month post-intervention, respectively]. This group of patients also displayed significant reduction in terms of emotional-distress (β= −0.424, 95% CI: −0.798 to −0.049, p = 0.027) and regimen-distress (β= −0.397, 95% CI: −0.702 to −0.091, p = 0.011) at three-month post-intervention and physician-related distress (β= −0.236, 95% CI: −0.466 to −0.006, p = 0.044) at one-week post-intervention. Significant improvement in quality of life (β= 4.151, 95% CI: 1.291, 7.012, p = 0.004) at three-month post-intervention was also observed in the intervention group. ConclusionsFindings provide empirical evidence for the values of an empowerment-based intervention program for patients with poorly controlled type 2 diabetes in increasing the empowerment level and perceived quality of life and reducing diabetes distress. Long-term effects of the intervention and its underlying mechanisms need further investigation.