Enhancing Adherence in Type 2 Diabetics

描述（由申请人提供）：本随机研究将测试基于社会认知理论（SCT）的干预措施，以改善3组不同的2型糖尿病患者（n=288）的方案依从性;（1）96例HbA 1c <8%且无并发慢性肾功能不全的个体，（2）96例HbA 1c>8%且无慢性肾功能不全的个体，（3）96例慢性肾功能不全患者，无论血糖控制如何。主要目标是：（a）确定与注意力控制条件相比，干预是否改善了对糖尿病自我管理方案的行为依从性，包括：饮食依从性，如通过饮食回忆测量并使用营养数据系统分析的;身体活动，如使用CHAMPS身体活动问卷和计步器读数通过自我报告报告的;如由ACCU-ECG监测器评估的对毛细血管葡萄糖自我监测的依从性，以及如由药物再填充率确定的对药物管理的依从性，（B）确定干预是否改善临床结果测量，包括：HbAlc、体重减轻和人体测量学，（c）探索自我效能是依从性的中介的程度，（d）探索干预的有效性相对于基线血糖控制和肾血管并发症变化的程度，以及（e）探索各种协变量的影响（药物、抑郁、社会支持、疾病的严重程度、一般健康和社会人口学特征，以及他们被招募的诊所）对干预的有效性的影响。假设#1是干预组参与者在遵守糖尿病管理方案的各种措施上比注意力控制组参与者表现更好。主要的依从性变量将是饮食摄入量和体力活动。假设#2是干预组参与者将具有比注意力控制组参与者更低的HbAlc水平。为期6个月的干预将侧重于建立对方案以下组成部分的掌握感：葡萄糖自我监测，药物自我管理，饮食和体育活动。干预将包括小组课程和个人咨询。干预参与者将被比较的注意力控制组暴露于研讨会和通讯。将在基线、3个月和6个月时进行测量。

DESCRIPTION (provided by applicant): This randomized study will test an intervention, based on social cognitive theory (SCT), to improve regimen adherence in 3 different groups of people with type 2 diabetes (n=288); (1) 96 individuals with HbA1cs<8% and no concurrent chronic renal insufficiency, (2) 96 individuals with HbA1c>8% and no chronic renal insufficiency, and (3) 96 individuals with chronic renal insufficiency regardless of glucose control. The primary aims are to: (a) determine if the intervention, compared to an attention control condition, improves behavioral adherence to the diabetes self-management regimen including: dietary adherence, as measured by dietary recalls and analyzed using the Nutrient Data System; physical activity as reported by self report using the CHAMPS Physical Activity Questionnaire and pedometer readings; adherence to capillary glucose self-monitoring as assessed by the ACCU-CHECK monitor, and adherence to medication management as determined by medication refill rates, (b) determine whether the intervention improves clinical outcome measures including: HbAlc, weight loss, and anthropometrics, (c) explore the extent to which self-efficacy is a mediator of adherence, (d) explore the extent to which the effectiveness of the intervention varies with respect to glycemic control and nephrovascular complications at baseline, and (e) explore the impact of a variety of covariates (medications, depression, social support, severity of disease, and general health and sociodemographic characteristics, and clinic from which they were recruited) on the effectiveness of the intervention. Hypothesis #1 is that intervention group participants will perform better than attention control group participants on various measures of adherence to the diabetes management regimen. Primary adherence variables will be dietary intake, and physical activity. Hypothesis #2 is that intervention group participants will have lower HbAlc levels than attention control group participants. The 6-month intervention will focus on building a sense of mastery over the following components of the regimen: glucose self-monitoring, medication self-management, diet, and physical activity. The intervention will include group classes and individual counseling. The intervention participants will be compared to an attention control group exposed to seminars and newsletters. Measurements will occur at baseline, 3 months, and 6 months.