Efficacy of the Diabetes Empowerment Self-management Interactive Research (DESIRE) programme in Chinese patients with poorly controlled type 2 diabetes: a randomised controlled trial.

BACKGROUND: Interventions that specifically target patients with poorly controlled type 2 diabetes have not received much attention, despite the numerous interventional studies in patients with diabetes. This study evaluated the effectiveness of a culturally tailored, empowerment-based self-management intervention programme in Chinese patients with poorly controlled type-2 diabetes.

METHODS: This randomised, controlled trial was conducted at two hospitals in Xi'an, China. 242 adult patients with poorly controlled type 2 diabetes (glycated haemoglobin [HbA1c] >7·5%) were randomly allocated (1:1) to receive a Diabetes Empowerment Self-management Interactive Research (DESIRE) programme or attentional control condition, by computer-generated randomisation with a block size of four. DESIRE was a nurse-led, patient-centred, empowerment-based programme consisting of six sessions on setting personally meaningful goals, making self-management action plans, and reflecting on the effect of self-management practices. HbA1c measurements, as primary outcome, were compared between the intervention and control groups at baseline and 3 months post-intervention. Data analysis adhered to intention-to-treat principles. Ethics approval was obtained from the Joint Chinese University of Hong Kong-New Territories East Clinical Research Ethics Committee. Written consent form were obtained from participants. The trial is registered at https://www.chictr.org.cn (ChiCTR-IPR-14005492).

FINDINGS: The intervention (n=121) and control (n=121) participants were similar at baseline. Participants in the intervention group had significant changes in HbA1c concentration (from mean 9·94% [SD 1·81] to 9·10% [2·03] in intervention group vs 10·15% [1·81] to 9·76% [2·20] in control group; effect size 0·31, 95% CI 0·05-0·58; p=0·030). Compared with participants in the control group, more participants in the intervention group achieved HbA1c targets of less than 7% (n=27 [22·3%] vs n=15 [12·4%]; relative risk 1·80, 95% CI 1·01-3·21; p=0·042). Sensitivity analysis showed consistent results for significant changes in HbA1c in the intervention group. No adverse events were observed.

INTERPRETATION: The DESIRE programme targeting patients with poorly controlled type 2 diabetes resulted in clinically significant improvement in glycaemic control. Future studies with a larger scale and longer duration are warranted to confirm the beneficial effects of such self-management programmes in this patient group.

FUNDING: None.