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Telephone intervention to improve diabetes control: a randomized trial in the New York City A1c registry
Chamany S, Walker EA, Schechter CB, Gonzalez JS, Davis NJ, Ortega FM, Carrasco J, Basch CE, Silver LD
American Journal of Preventive Medicine 2015 Dec;49(6):832-841
clinical trial
7/10 [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: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

INTRODUCTION: Scalable self-management interventions are necessary to address suboptimal diabetes control, especially among minority populations. The study tested the effectiveness of a telephone behavioral intervention in improving glycemic control among adults with diabetes in the New York City A1c Registry. DESIGN: RCT comparing a telephone intervention to print-only intervention in the context of the A1c Registry program. SETTING/PARTICIPANTS: Nine hundred forty-one adults with diabetes and hemoglobin A1c (A1c) > 7% from a low-income, predominantly Latino population in the South Bronx were recruited from the A1c Registry. INTERVENTION: All study participants were mailed print diabetes self-management materials at baseline and modest lifestyle incentives quarterly. Only the telephone participants received four calls from health educators evenly spaced over 1 year if baseline A1c was > 7% to 9%, or eight calls if baseline A1c was > 9%. Medication adherence was the main behavioral focus and, secondarily, nutrition and exercise. MAIN OUTCOME MEASURES: Primary outcome was difference between two study arms in change in A1c from baseline to 1 year. Secondary outcomes included diabetes self-care activities, including self-reported medication adherence. Data were collected in 2008 to 2012 and analyzed in 2012 to 2014. RESULTS: Participants were predominantly Latino (67.7%) or non-Latino black (28%), with 69.7% foreign-born and 55.1% Spanish-speaking. Among 694 (74%) participants with follow-up A1c, mean A1c decreased by 0.9 (SD 0.1) among the telephone group compared with 0.5 (SD 0.1) among the print-only group, a difference of 0.4 (95% CI 0.09 to 0.74, p = 0.01). The intervention had significant effect when baseline A1c was > 9%. Both groups experienced similar improvements in self-care activities, medication adherence, and intensification. CONCLUSIONS: A telephone intervention delivered by health educators can be a clinically effective tool to improve diabetes control in diverse populations, specifically for those with worse metabolic control identified using a registry. This public health approach could be adopted by health systems supported by electronic record capabilities. CLINICALTRIALS.GOV REGISTRATION: NCT00797888.

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