Effectiveness of a Diabetes Education Program based on Tailored interventions and Theory of Planned Behaviour: Cluster randomized controlled trial protocol

Aim To measure the Effectiveness of a Diabetes Education Program for people with T2DM, based on Tailored interventions and the Theory of Planned Behaviour. Design Cluster randomized controlled clinical trial. Methods This multicentre study will be carried out at 30 primary healthcare centres, where 436 persons with Type 2 Diabetes Mellitus (T2DM), aged between 18–75 years, will be recruited. The experimental educational program to be applied is modelled using components obtained from a systematic review and prior qualitative analysis. In addition, a taxonomy of nursing practice is used to standardize the program, based on the Theory of Planned Behaviour as a conceptual model. The intervention will be carried out by community nurses, using ADAPP‐Ti®, an application developed with FileMaker Pro v.18. The control group will receive usual care and data will be collected at 6, 12, and 18 months, for both groups. The primary outcome considered will be glycosylated haemoglobin and cardiovascular factors, while the secondary ones will be tobacco consumption, body mass index, barriers to self‐care, health‐related quality of life, and lifestyle modification. The protocol was approved by the Ethics Committee of the Province of Malaga (Spain) in November 2014. Discussion The degree of metabolic control in T2DM is not always associated with healthy lifestyles and significant levels of medication are often prescribed to achieve clinical objectives. An intervention focused on needs, based on the best available evidence and a solid conceptual framework, might successfully consolidate appropriate self‐care behaviour in this population. Impact The study will result in the publication of an educational program featuring well‐defined interventions and activities that will enable clinicians to tailor health care to the individual's needs and to combat treatment inertia in attending this population. 摘要 目标 以定制干预措施和计划行为理论为基础,对2型糖尿病患者的糖尿病教育计划的有效性进行评估。 设计 群随机对照临床试验。 方法 这项多中心研究将在30个初级医疗中心进行,将招募436名年龄在18‐75岁之间的2型糖尿病(T2DM)患者。将采用的实验教育方案是使用从系统回顾和先前的定性分析中获得的内容进行建模。此外,以计划行为理论为概念模型,采用护理实践分类法来规范程序。干预将由社区护士使用由FileMaker Pro v.18开发的ADAPP‐Ti®进行。对照组将接受常规护理,并在6个月、12个月和18个月收集数据。考虑的主要结果是糖化血红蛋白和心血管因素,次要结果是烟草消费、体重指数、自我保健障碍、健康相关生活质量和生活方式改变。2014年11月,马拉加省(西班牙)伦理委员会批准了该方案。 讨论 2型糖尿病患者的代谢控制程度并不总是与健康的生活方式相关,为了达到临床目标,通常会开出大量药物。以现有的最佳证据和坚实的概念框架为基础,以需求为重点的干预措施可能会成功地巩固这一群体适当的自我保健行为。 影响 这项研究将导致一项教育计划的出版,其特点是明确的干预措施和活动,使临床医生能够根据个人需求量身定制医疗保健,并克服治疗惯性。