title: Comparative effectiveness of goal setting in diabetes mellitus group clinics: randomized clinical trial.
abstract: 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 (HbA(1c)) 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 A(1c) levels were compared after intervention and at the 1-year follow-up.
  
  
  RESULTS
  Participants in the EPIC intervention had significantly greater improvements in HbA(1c) levels immediately following the active intervention (8.86%-8.04% vs 8.74%-8.70% of total hemoglobin; mean [SD] between-group difference 0.67% [1.3%]; P=.03), and these differences persisted at the 1 year follow-up (0.59% [1.4%], P=.05). A repeated-measures analysis using all study time points found a significant time-by-treatment interaction effect on HbA(1c) levels favoring the EPIC intervention (F(2,85)=3.55; P=.03). The effect of the time-by-treatment interaction seems to be partially mediated by DM self-efficacy (F(1,85)=10.39; P=.002).
  
  
  CONCLUSIONS
  Primary care-based DM group clinics that include structured goal-setting approaches to self-management can significantly improve HbA(1c) levels after intervention and maintain improvements for 1 year. Trial Registration clinicaltrials.gov Identifier: NCT00481286.
authors.affiliation: Michael E. De-Bakey VAMC (152), Houston Health Services Research and Development Center of Excellence, 2002 Holcombe, Houston, TX 77030, USA. anaik@bcm.edu
authors.forename: Aanand D
authors.initials: AD
authors.lastname: Naik
authors.forename: Nynikka
authors.initials: N
authors.lastname: Palmer
authors.forename: Nancy J
authors.initials: NJ
authors.lastname: Petersen
authors.forename: Richard L
authors.initials: RL
authors.lastname: Street
authors.forename: Radha
authors.initials: R
authors.lastname: Rao
authors.forename: Maria
authors.initials: M
authors.lastname: Suarez-Almazor
authors.forename: Paul
authors.initials: P
authors.lastname: Haidet
mesh_terms: D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000523:psychology / Q000628:therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010347:Patient Care Planning; D011320:Primary Health Care; D016896:Treatment Outcome
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; C517652:hemoglobin A1c protein, human