Enhancing Adherence in Type 2 Diabetics

描述（由申请人提供）：本随机研究将测试一种基于社会认知理论（SCT）的干预措施，以改善3组不同的2型糖尿病患者（n=288）的治疗依从性；(1) 96例HbA1c <8%，无并发慢性肾功能不全；(2)96例HbA1c≤8%，无并发慢性肾功能不全；(3)96例不论血糖控制情况，均存在慢性肾功能不全。主要目的是：(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，通过饮食回忆来衡量，并使用营养数据系统进行分析；使用CHAMPS体力活动问卷和计步器读数自报体力活动；(b)确定干预是否改善了临床结果指标，包括：(c)探索自我效能感在多大程度上是依从性的中介，(d)探索干预的有效性在多大程度上随基线时血糖控制和肾血管并发症的变化而变化，(e)探索各种协变量（药物、抑郁、社会支持、疾病严重程度、总体健康和社会人口特征）的影响。以及他们被招募的诊所)干预的有效性。假设1是干预组的参与者在坚持糖尿病管理方案的各种措施上比注意力控制组的参与者表现得更好。主要的依从性变量将是饮食摄入和身体活动。假设2是干预组参与者的HbAlc水平低于注意控制组参与者。为期6个月的干预将侧重于建立对以下方案组成部分的掌握感：葡萄糖自我监测，药物自我管理，饮食和身体活动。干预将包括小组课程和个人咨询。参与干预的参与者将与关注研讨会和时事通讯的注意力控制组进行比较。测量将在基线、3个月和6个月时进行。

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.