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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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