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Effectiveness of a self-management intervention in patients with screen-detected type 2 diabetes |
Thoolen B, de Ridder D, Bensing J, Maas C, Griffin S, Gorter K, Rutten G |
Diabetes Care 2007 Nov;30(11):2832-2837 |
clinical trial |
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To examine the effectiveness of a theory-driven self-management course in reducing cardiovascular risk in patients with screen-detected type 2 diabetes, taking ongoing medical treatment into account. RESEARCH DESIGN AND METHODS: A total of 196 screen-detected patients, receiving either intensive pharmacological or usual-care treatment since diagnosis (3 to 33 months previously), were subsequently randomized to a control or intervention condition (self-management course). A 2x2 factorial design evaluated the behavioral intervention (self-management course versus control) nested within the medical treatment (intensive versus usual-care), using multilevel regression modeling to analyze changes in patients' BMI, A1C, blood pressure (BP), and lipid profiles over 12 months, from the start of the 3-month course to 9-month follow-up. RESULTS: The self-management course significantly reduced BMI (-0.77 kg/m2) and systolic BP (-6.2 mmHg) up until the 9-month follow-up, regardless of medical treatment. However, intensive medical treatment was also independently associated with lower BP, A1C, total cholesterol, and LDL before the course and further improvements in systolic BP (-4.7 mmHg). Patients receiving both intensive medical treatment and the self-management course therefore had the best outcomes. CONCLUSIONS: This self-management course was effective in achieving sustained reductions in weight and BP, independent of medical treatment. A combination of behavioral and medical interventions is particularly effective in reducing cardiovascular risk in newly diagnosed patients.
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