Kullgren Jeffrey T, Youles Bradley, Shetty Shaina, Richardson Caroline, Fagerlin Angela, Heisler Michele
VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, PO Box 130170, Ann Arbor, MI, 48113-0170, USA.
Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
Trials. 2017 Apr 8;18(1):167. doi: 10.1186/s13063-017-1887-6.
Prediabetes is an asymptomatic condition in which patients' blood glucose levels are higher than normal but do not meet diagnostic criteria for type 2 diabetes mellitus (T2DM). A key window of opportunity to increase engagement of patients with prediabetes in strategies to prevent T2DM is when they are screened for T2DM and found to have prediabetes, yet the effects of this screening and brief counseling are unknown.
In this parallel-design randomized controlled trial we will recruit 315 non-diabetic patients from the Ann Arbor VA Medical Center (AAVA) who have one or major risk factors for T2DM and an upcoming primary care appointment at the AAVA, but have not had a hemoglobin A1c (HbA1c) test to screen for T2DM in the previous 12 months. After informed consent, participants will complete a baseline survey and be randomly assigned to, at the time of their next primary care appointment, one of two arms: (1) to have a hemoglobin A1c (HbA1c) test to screen for T2DM and receive brief, standardized counseling about these results or (2) to review a brochure about clinical preventive services. Participants will complete surveys 2 weeks, 3 months, and 12 months after their primary care appointment, and a weight measurement 12 months after their primary care appointment. The primary outcome is weight change after 12 months. The secondary outcomes are changes in perception of risk for T2DM; knowledge of T2DM prevention; self-efficacy and motivation to prevent T2DM; use of pharmacotherapy for T2DM prevention; physical activity; participation in weight management programs; and mental health. Quantitative analyses will compare outcomes among participants in the HbA1c test arm found to have prediabetes with participants in the brochure arm. Among participants in the HbA1c test arm found to have prediabetes we will conduct semi-structured interviews about their understanding of and reactions to receiving a prediabetes diagnosis.
This trial will generate foundational data on the effects of a prediabetes diagnosis and brief counseling on patients' preventive behaviors and mediators of these behaviors that will enable the development of novel strategies to improve patient engagement in T2DM prevention.
ClinicalTrials.gov, NCT02747108 . Registered on 18 April 2016.
糖尿病前期是一种无症状的状态，患者的血糖水平高于正常，但未达到2型糖尿病（T2DM）的诊断标准。提高糖尿病前期患者参与预防T2DM策略的关键时机是在他们接受T2DM筛查并被发现患有糖尿病前期时，然而这种筛查和简短咨询的效果尚不清楚。
在这项平行设计的随机对照试验中，我们将从安阿伯退伍军人医疗中心（AAVA）招募315名非糖尿病患者，这些患者有一个或多个T2DM主要危险因素，且即将在AAVA进行初级保健预约，但在过去12个月内未进行过糖化血红蛋白（HbA1c）检测以筛查T2DM。在获得知情同意后，参与者将完成基线调查，并在下次初级保健预约时随机分配到两个组之一：（1）进行糖化血红蛋白（HbA1c）检测以筛查T2DM，并接受关于这些结果的简短、标准化咨询；或（2）阅读一本关于临床预防服务的手册。参与者将在初级保健预约后2周、3个月和12个月完成调查，并在初级保健预约后12个月进行体重测量。主要结局是12个月后的体重变化。次要结局包括对T2DM风险认知的变化；T2DM预防知识；预防T2DM的自我效能感和动机；用于预防T2DM的药物治疗使用情况；身体活动；参与体重管理计划；以及心理健康。定量分析将比较糖化血红蛋白检测组中被发现患有糖尿病前期的参与者与手册组参与者的结局。在糖化血红蛋白检测组中被发现患有糖尿病前期的参与者中，我们将对他们对糖尿病前期诊断的理解和反应进行半结构化访谈。
这项试验将产生关于糖尿病前期诊断和简短咨询对患者预防行为及其行为调节因素影响的基础数据，这将有助于制定新的策略来提高患者参与T2DM预防的程度。
ClinicalTrials.gov，NCT02747108。于2016年4月18日注册。
