Effectiveness of a patient-centred, empowerment-based intervention programme among patients with poorly controlled type 2 diabetes: A randomised controlled trial

Abstract

Background: Despite extensive efforts and advances in evidence-based diabetes management, poor glycaemic control still remains a challenge in many countries. There is a paucity of research addressing the needs of patients with poorly controlled type 2 diabetes, or exploring the effectiveness of empowerment-based interventions in this vulnerable population.

Objectives: To evaluate the effectiveness of a patient-centred, empowerment-based programme on glycaemic control and self-management behaviours among patients with poorly controlled type 2 diabetes.

Design: A prospective multi-centre, single-blind, randomised controlled trial.

Settings and participants: Adult patients with poorly controlled type 2 diabetes [Haemoglobin A1c (HbA1c) ≥7.5% in the recent six months] were recruited from two tertiary hospitals in Xi'an city, China.

Methods: A total of 242 eligible patients were recruited and randomly assigned to the intervention or attentional control groups after baseline measurement. Participants in the intervention group received a 6-week patient-centred, empowerment-based self-management programme, which is theoretically grounded on the principles of the Empowerment Process Model-setting personally meaningful goals, taking action towards goals and reflecting on the impact of action plans. Those in the attentional control group received health education classes and post-discharge follow-up. Outcome measures included glycaemic control (measured by HbA1c) and self-management behaviours. Data were collected at baseline, and at 8th and 20th week after enrolment. Intervention effect were analysed using the generalised estimating equation model on the basis of the intention-to-treat principle.

Results: Compared with the attention control group, the intervention group showed a non-significant HbA1c reduction of 0. 476% (Cohen's d effect size=0.31, p=0.162). The intervention group exhibited significant improvements in general diet management at the 8th-week (β=0.740; p=0.013), specific diet management at 8th-week (β=0.646; p=0.022) and 20th-week (β=0.517; p=0.043), and blood glucose self-monitoring at both the 8th- (β=0.793; p=0.009) and 20th-week (β=0.739; p=0.017) follow-ups. No intervention-related adverse events were observed.

Conclusions: Findings indicate that the patient-centred, empowerment-based self-management intervention program did not induce a significant HbA1c reduction. Whereas this intervention yields improvements in diet management and blood glucose self-monitoring among patients with poorly controlled type 2 diabetes.

Keywords: Behaviour; Clinical trial; Empowerment; Poorly controlled type 2 diabetes; Self-management education; Transitional care.