The feasibility and efficacy of a community-based multifactorial intervention to improve the cardiovascular risk factor control among patients with type 2 diabetes: A 2-year cluster randomized trial.

TRIAL DESIGN: Our study is to investigate the feasibility and effectiveness of multiple cardiovascular factors intervention (MFI) in type 2 diabetes patients in China's primary care setting. METHODS: We performed a cluster randomized trial to compare the proportion of patients achieved the targets between usual care group (control, 9 sites, n = 868) and MFI group (8 sites, n = 739) among patients with type 2 diabetes in primary care setting. Logistic regression model with random effects was used to estimate the association of the effect of intervention and the proportion achieved the targets. RESULTS: At baseline, the end of 1 year, and 2 years follow-up, the proportion of patients achieved all 3 target goals (HbA1c < 7.0%, blood pressure < 130/80 mm Hg and low-density lipoprotein cholesterol < 2.6 mmol/L) were 5.7%, 5.9%, 5.7% in the control group and 5.9%, 10.6%, 12.3% in the MFI group. After adjusting sex, age, diabetes duration, body mass index, HbA1c, blood pressure, and low-density lipoprotein cholesterol at baseline, there was no difference between the 2 groups (OR (95% CI): 1.27 (0.38-4.27) and 1.86 (0.79-4.38) for the first year and second year, respectively). When stratified by payment method, the patients with medical insurance or public expenses had a higher proportion achieved target goals (6.9% vs 16.4%, OR (95% CI): 2.30 (1.04-5.08)) in the second year. CONCLUSIONS: The controlling of cardiovascular risk factor targets remains suboptimal among patients with type 2 diabetes in primary care setting. MFI in type 2 diabetes improved cardiovascular disease risk profile, especially in the patients with medical insurance.