Reininger Belinda M, Lee MinJae, Hessabi Manouchehr, Mitchell-Bennett Lisa A, Sifuentes Maribel R, Guerra Jose A, Ayala Ciara D, Xu Tianlin, Polletta Valerie, Flynn Amy, Rahbar Mohammad H
Department of Health Promotion and Behavioral Sciences, The University of Texas Health Science Center at Houston, School of Public Health, Brownsville Regional Campus, Brownsville, Texas, USA
Division of Clinical and Translational Sciences, Department of Internal Medicine, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas, USA.
BMJ Open Diabetes Res Care. 2020 May;8(1). doi: 10.1136/bmjdrc-2019-000867.
This randomized controlled trial investigated community-clinical intervention strategies for a Mexican American population who had not demonstrated control of their diabetes. We tested a control program (Salud y Vida 1.0) supporting diabetes management versus an enhanced version (Salud y Vida 2.0) for reductions in HbA1c at 12 months.
Adults with uncontrolled diabetes (n=353) were enrolled if they had an HbA1c≥9.0% during a program or doctor's visit between 6 and 36 months of their receipt of SyV 1.0 services, were patients at one of two clinics in local counties, and had an HbA1c≥8.0% at SyV 2.0 baseline enrollment. The control and intervention arms were coordinated by community health workers and the intervention arm included the control program enhanced with medication therapy management; behavioral health services; peer-led support groups; and additional community-based lifestyle programs also open to the family.
At 12 months, both study arms improved HbA1c (mean, (CI), Control (-0.47 (-0.74 to -0.20)) and intervention (-0.48 (-0.76 to -0.19)). The intervention group maintained HbA1c levels after month 6, whereas control group HbA1c levels slightly increased (adjusted mean from 9.83% at month 6%-9.90% at month 12). Also, HbA1c was examined by level of participant engagement. The high engagement group showed a decreasing trend over the study period, while control and lower engagement groups failed to maintain HbA1c levels at month 12.
Improved HbA1c was found among a population that had not demonstrated diabetes management prior; however, mean HbA1c values were above clinical guideline recommendations. The randomized control trial findings provide additional evidence that extended time and intervention supports may be needed for populations experiencing inequities in social determinants of health.
NCT04035395.
本随机对照试验研究了针对未实现糖尿病控制的墨西哥裔美国人的社区 - 临床干预策略。我们测试了一个支持糖尿病管理的对照项目（健康与生活1.0）与一个增强版（健康与生活2.0），以观察12个月时糖化血红蛋白（HbA1c）的降低情况。
未控制糖尿病的成年人（n = 353），如果在接受SyV 1.0服务的6至36个月期间，在项目或医生就诊时HbA1c≥9.0%，是当地县两家诊所之一的患者，且在SyV 2.0基线入组时HbA1c≥8.0%，则纳入研究。对照组和干预组由社区卫生工作者协调，干预组包括通过药物治疗管理增强的对照项目；行为健康服务；同伴主导的支持小组；以及也向家庭开放的其他基于社区的生活方式项目。
在12个月时，两个研究组的HbA1c均有所改善（均值，（置信区间），对照组（-0.47（-0.74至-0.20））和干预组（-0.48（-0.76至-0.19））。干预组在第6个月后维持了HbA1c水平，而对照组的HbA1c水平略有上升（从第6个月的9.83%调整均值至第12个月的9.90%）。此外，根据参与者参与程度对HbA1c进行了检查。高参与度组在研究期间呈下降趋势，而对照组和低参与度组在第12个月未能维持HbA1c水平。
在之前未实现糖尿病管理的人群中发现HbA1c有所改善；然而，平均HbA1c值高于临床指南建议。随机对照试验结果提供了更多证据，表明对于在健康社会决定因素方面存在不平等的人群，可能需要更长时间和干预支持。
NCT04035395。
