MRC Epidemiology Unit, Box 285, Addenbrooke's Hospital, Hills Road, Cambridge, CB2 0QQ, UK.
BMC Public Health. 2011 Apr 4;11:211. doi: 10.1186/1471-2458-11-211.
The increasing prevalence of type 2 diabetes poses both clinical and public health challenges. Cost-effective approaches to prevent progression of the disease in primary care are needed. Evidence suggests that intensive multifactorial interventions including medication and behaviour change can significantly reduce cardiovascular morbidity and mortality among patients with established type 2 diabetes, and that patient education in self-management can improve short-term outcomes. However, existing studies cannot isolate the effects of behavioural interventions promoting self-care from other aspects of intensive primary care management. The ADDITION-Plus trial was designed to address these issues among recently diagnosed patients in primary care over one year.
METHODS/DESIGN: ADDITION-Plus is an explanatory randomised controlled trial of a facilitator-led, theory-based behaviour change intervention tailored to individuals with recently diagnosed type 2 diabetes. 34 practices in the East Anglia region participated. 478 patients with diabetes were individually randomised to receive (i) intensive treatment alone (n = 239), or (ii) intensive treatment plus the facilitator-led individual behaviour change intervention (n = 239). Facilitators taught patients key skills to facilitate change and maintenance of key behaviours (physical activity, dietary change, medication adherence and smoking), including goal setting, action planning, self-monitoring and building habits. The intervention was delivered over one year at the participant's surgery and included a one-hour introductory meeting followed by six 30-minute meetings and four brief telephone calls. Primary endpoints are physical activity energy expenditure (assessed by individually calibrated heart rate monitoring and movement sensing), change in objectively measured dietary intake (plasma vitamin C), medication adherence (plasma drug levels), and smoking status (plasma cotinine levels) at one year. We will undertake an intention-to-treat analysis of the effect of the intervention on these measures, an assessment of cost-effectiveness, and analyse predictors of behaviour change in the cohort.
The ADDITION-Plus trial will establish the medium-term effectiveness and cost-effectiveness of adding an externally facilitated intervention tailored to support change in multiple behaviours among intensively-treated individuals with recently diagnosed type 2 diabetes in primary care. Results will inform policy recommendations concerning the management of patients early in the course of diabetes. Findings will also improve understanding of the factors influencing change in multiple behaviours, and their association with health outcomes.
2 型糖尿病的患病率不断上升，既给临床带来了挑战，也对公共卫生构成了挑战。需要在基层医疗中找到具有成本效益的方法来防止疾病的进展。有证据表明，强化多因素干预措施，包括药物治疗和行为改变，可以显著降低已确诊 2 型糖尿病患者的心血管发病率和死亡率，而患者自我管理教育可以改善短期结局。然而，现有研究无法将促进自我护理的行为干预的效果与强化初级保健管理的其他方面区分开来。ADDITION-Plus 试验旨在在一年的时间里解决初级保健中最近确诊的患者的这些问题。
方法/设计：ADDITION-Plus 是一项解释性随机对照试验，针对的是最近被诊断患有 2 型糖尿病的个体，采用的是经过精心设计的、基于理论的行为改变干预措施，由一名促进者来指导。东英吉利地区的 34 家诊所参与了这项研究。478 名糖尿病患者被单独随机分配接受（i）强化治疗（n = 239）或（ii）强化治疗加促进者指导的个体行为改变干预（n = 239）。促进者教授患者关键技能，以促进行为改变和维持（体力活动、饮食改变、药物依从性和吸烟），包括设定目标、制定行动计划、自我监测和养成习惯。该干预措施在参与者的手术中进行了一年，包括一次一小时的介绍性会议，随后进行六次 30 分钟的会议和四次简短的电话。主要终点是一年时的体力活动能量消耗（通过个体校准的心率监测和运动感应来评估）、客观测量的饮食摄入变化（血浆维生素 C）、药物依从性（血浆药物水平）和吸烟状况（血浆可替宁水平）。我们将对干预措施对这些指标的效果进行意向治疗分析，评估成本效益，并分析队列中行为改变的预测因素。
ADDITION-Plus 试验将确定在基层医疗中对最近被诊断患有 2 型糖尿病的个体进行强化治疗的同时，增加一种专门设计的、外部促进的干预措施，以支持多种行为改变的中期有效性和成本效益。结果将为早期糖尿病患者的管理提供政策建议。研究结果还将提高对影响多种行为变化的因素及其与健康结果的关系的理解。
