Escuela Andaluza de Salud Pública, Campus Universitario de Cartuja, Cuesta del Observatorio 4, Apdo, 2070, 18080, Granada, Spain.
BMC Health Serv Res. 2013 Oct 23;13:433. doi: 10.1186/1472-6963-13-433.
In the last decades the presence of social inequalities in diabetes care has been observed in multiple countries, including Spain. These inequalities have been at least partially attributed to differences in diabetes self-management behaviours. Communication problems during medical consultations occur more frequently to patients with a lower educational level. The purpose of this cluster randomized trial is to determine whether an intervention implemented in a General Surgery, based in improving patient-provider communication, results in a better diabetes self-management in patients with lower educational level. A secondary objective is to assess whether telephone reinforcement enhances the effect of such intervention. We report the design and implementation of this on-going study.
METHODS/DESIGN: The study is being conducted in a General Practice located in a deprived neighbourhood of Granada, Spain. Diabetic patients 18 years old or older with a low educational level and inadequate glycaemic control (HbA1c > 7%) were recruited. General Practitioners (GPs) were randomised to three groups: intervention A, intervention B and control group. GPs allocated to intervention groups A and B received training in communication skills and are providing graphic feedback about glycosylated haemoglobin levels. Patients whose GPs were allocated to group B are additionally receiving telephone reinforcement whereas patients from the control group are receiving usual care. The described interventions are being conducted during 7 consecutive medical visits which are scheduled every three months. The main outcome measure will be HbA1c; blood pressure, lipidemia, body mass index and waist circumference will be considered as secondary outcome measures. Statistical analysis to evaluate the effectiveness of the interventions will include multilevel regression analysis with three hierarchical levels: medical visit level, patient level and GP level.
The results of this study will provide new knowledge about possible strategies to promote a better diabetes self-management in a particularly vulnerable group. If effective, this low cost intervention will have the potential to be easily incorporated into routine clinical practice, contributing to decrease health inequalities in diabetic patients.
Clinical Trials U.S. National Institutes of Health, NCT01849731.
在过去的几十年中，多个国家包括西班牙在内，都观察到了糖尿病治疗中存在社会不平等现象。这些不平等现象至少部分归因于糖尿病自我管理行为的差异。在医疗咨询期间，文化程度较低的患者更容易出现沟通问题。本项集群随机试验的目的是确定在以改善医患沟通为基础的普通外科实施的干预措施是否会使文化程度较低的患者更好地进行糖尿病自我管理。次要目的是评估电话强化是否会增强这种干预的效果。我们报告了这项正在进行的研究的设计和实施情况。
方法/设计：该研究正在西班牙格拉纳达一个贫困社区的一家普通外科诊所进行。招募年龄在 18 岁或以上、文化程度较低且血糖控制不佳（HbA1c＞7%）的糖尿病患者。将全科医生（GP）随机分为三组：干预 A 组、干预 B 组和对照组。为接受干预的 A 组和 B 组的全科医生提供沟通技巧培训，并提供有关糖化血红蛋白水平的图形反馈。被分配到 B 组的患者还会接受电话强化，而对照组的患者则接受常规护理。上述干预措施将在连续 7 次的医疗就诊中进行，每次就诊间隔 3 个月。主要结局指标为 HbA1c；血压、血脂、体重指数和腰围将被视为次要结局指标。评估干预效果的统计分析将包括具有三个层次的多层次回归分析：医疗就诊层次、患者层次和全科医生层次。
这项研究的结果将提供有关促进特别脆弱群体更好地进行糖尿病自我管理的可能策略的新知识。如果有效，这种低成本干预措施将有可能很容易地纳入常规临床实践，有助于减少糖尿病患者的健康不平等现象。
美国国立卫生研究院临床试验 U.S. National Institutes of Health，NCT01849731。
