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| Effect of group patient education on glycemic control among people living with type 2 diabetes in Vietnam: a randomized controlled single-center trial [with consumer summary] |
| Thanh HTK, Tien TM |
| Diabetes Therapy 2021 May;12(5):1503-1521 |
| clinical trial |
| 5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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INTRODUCTION: In low- to middle-income countries such as Vietnam, urgent measures are required to prevent and control type 2 diabetes and its complications. This study measured the effect of a 3-month patient education and self-management intervention in a low-resource setting on diabetes knowledge and levels of blood glucose control. METHODS: This was a single-center randomized controlled study among adult outpatients with type 2 diabetes. Patients were randomly assigned to 3-month community intervention consisting of group education for type 2 diabetes knowledge, diet, exercise in combination with usual diabetes care, or to usual diabetes care alone (control). Diabetes knowledge was measured with a modified Michigan University Diabetes Knowledge Test (MDKT). Other study outcomes included change in mean HbA1c, fasting blood glucose (FBG), and systolic blood pressure (SBP). RESULTS: A total of 364 patients were randomized, 182 to the intervention group and 182 to control. The two groups were similar regarding main baseline characteristics. The male/female ratio was 45.1%/54.9% and mean age was 62.2 +/- 9.3 years. Approximately half the patients (48.1%) were overweight and 15.7% were obese, mean baseline HbA1c was 8.21 +/- 1.92%, and only 29.9% of participants had a baseline HbA1c < 7.0%. At baseline, diabetes knowledge was "very poor" or "poor" in 63.7% of patients. After a 3-month follow-up, the proportion achieving the target MDKT score increased from 37.4% to 81.3% in the intervention group and from 35.2% to 51.7% in the control (between-group difference p < 0.001). The estimate (SD) of the difference between intervention and control groups was -1.63 (2.16), 95% CI -2.07 to -1.18. Mean changes from baseline HbA1c were -0.54 +/- 1.41% and -0.18 +/- 1.33% in the intervention and control groups, respectively (p = 0.012). Among those with poor glycemic control (HbA1c >= 7%) at baseline, mean changes at 3 months were -0.80 +/- 1.52% versus 0.41 +/- 1.47%, respectively, (p = 0.013). Statistically significant decreases in FBG and SBP were also observed in the intervention group at 3 months, but not in the control group. Multivariate analysis revealed the variables with the strongest influence on blood glucose control at 3 months were study group, baseline MDKT score, diabetes duration, and baseline HbA1c (all p <= 0.05). CONCLUSION: Provision of a structured educational program to Vietnamese people living with type 2 diabetes is effective at improving disease knowledge and is associated with better glycemic control. Larger and longer-term studies are now warranted to confirm these findings. TRIAL REGISTRATION: This trial was retrospectively registered on 27 May 2020 through the https://ClinicalTrials.gov site with the following identifier NCT04403841.
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