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Comparative effectiveness of goal setting in diabetes mellitus group clinics: randomized clinical trial |
Naik AD, Palmer N, Petersen NJ, Street RL Jr, Rao R, Suarez-Almazor M, Haidet P |
Archives of Internal Medicine 2011 Mar 14;171(5):453-459 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; 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* |
BACKGROUND: Diabetes mellitus (DM) group clinics can effectively control hypertension, but data to support glycemic control are equivocal. This study evaluated the comparative effectiveness of 2 DM group clinic interventions on glycosylated hemoglobin (HbA1c) levels in primary care. METHODS: Eighty-seven participants were recruited from a DM registry of a single regional Veterans Affairs medical center to participate in an open, randomized comparative effectiveness study. Two primary care-based DM group interventions of 3 months' duration were compared. Empowering Patients in Care (EPIC) was a clinician-led, patient-centered group clinic consisting of 4 sessions on setting self-management action plans (diet, exercise, home monitoring, medications, etc) and communicating about progress with action plans. The comparison intervention consisted of group education sessions with a DM educator and dietician followed by an additional visit with one's primary care provider. Hemoglobin A1c levels were compared after intervention and at the 1-year follow-up. RESULTS: Participants in the EPIC intervention had significantly greater improvements in HbA1c levels immediately following the active intervention (8.86% to 8.04% versus 8.74% to 8.70% of total hemoglobin; mean (SD) between-group difference 0.67% (1.3%); p = 0.03), and these differences persisted at the 1 year follow-up (0.59% (1.4%), p = 0.05). A repeated-measures analysis using all study time points found a significant time-by-treatment interaction effect on HbA1c levels favoring the EPIC intervention (F[2,85] = 3.55; p = 0.03). The effect of the time-by-treatment interaction seems to be partially mediated by DM self-efficacy (F[1,85] = 10.39; p = 0.002). CONCLUSION: Primary care-based DM group clinics that include structured goal-setting approaches to self-management can significantly improve HbA1c levels after intervention and maintain improvements for 1 year. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00481286.
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