Párraga-Martínez Ignacio, Rabanales-Sotos Joseba, Lago-Deibe Fernando, Téllez-Lapeira Juan M, Escobar-Rabadán Francisco, Villena-Ferrer Alejandro, Blasco-Valle Mariano, Ferreras-Amez José M, Morena-Rayo Susana, del Campo-del Campo José M, Ayuso-Raya Maria Candelaria, Pérez-Pascual José J
La Roda Health Centre, Health Care Service of Castilla-La Mancha, C/Mártires 63, 02630 Albacete, La Roda, Spain.
BMC Cardiovasc Disord. 2015 Jan 19;15:8. doi: 10.1186/1471-2261-15-8.
In subjects with hypercholesterolaemia, cholesterol values remain above guideline levels. One of the limiting factors to the achievement of goals in such patients is therapeutic non-adherence. The aim of this study is to assess the effectiveness of an intervention designed to improve control of hypercholesterolaemic patients, consisting of a combined strategy that would include the delivery of printed information, treatment-compliance check cards and the dispatch of text messages as complementary measures in support of the intervention at the general practitioner's practice.
METHODS/DESIGN: A randomised, parallel-group clinical trial will be conducted at the family medicine outpatient facilities of eight health centres in three of Spain's Autonomous Regions (Comunidades Autónomas), covering a total of 358 subjects aged 18 years or over with diagnosis of hypercholesterolaemia. Patients in the intervention group will be supplied with printed material with information on the disease and its management, mobile-telephone text messages with guideline summaries, reminders of forthcoming appointments and/or arrangements for making new appointments in the event of non-attendance, and self-report cards to check compliance with recommendations. Both groups -intervention and control- will receive routine recommendations from their physicians in accordance with current European clinical practice guidelines for hypercholesterolaemia and cardiovascular risk management. As regards the measurements to be made, the main variable is the proportion of subjects who attain the low density lipoprotein cholesterol levels set as a target across a follow-up period of 24 months. The secondary variables are as follows: adherence to recommendations on lifestyle and adherence to drug treatment; variation in lipid profiles and cardiovascular risk levels; appearance of cardiovascular events; physical activity; food consumption; smoking habit; anthropometric measures; blood pressure; health problems; use of hypolipidaemic agents; socio-demographic data; beliefs and expectations about preventive recommendations; and degree of satisfaction with the combined strategy.
Should this intervention prove effective, a recommendation could be issued on the application of this combined strategy to subjects with hypercholesterolaemia. It is a simple, relatively inexpensive intervention.
ClinicalTrials.gov: NCT02314663.
在高胆固醇血症患者中，胆固醇值仍高于指南水平。此类患者实现治疗目标的限制因素之一是治疗依从性差。本研究的目的是评估一种旨在改善高胆固醇血症患者控制情况的干预措施的有效性，该干预措施包括一项综合策略，其中包括提供印刷信息、治疗依从性检查卡以及发送短信，作为在全科医生诊所支持该干预措施的补充措施。
方法/设计：将在西班牙三个自治区的八个健康中心的家庭医学门诊设施中进行一项随机平行组临床试验，共纳入358名年龄在18岁及以上、诊断为高胆固醇血症的受试者。干预组患者将获得有关疾病及其管理的印刷材料、带有指南摘要的手机短信、即将到来的预约提醒和/或在未就诊时安排新预约的信息，以及用于检查是否遵守建议的自我报告卡。干预组和对照组都将根据当前欧洲高胆固醇血症和心血管风险管理临床实践指南接受医生的常规建议。至于要进行的测量，主要变量是在24个月的随访期内达到设定为目标的低密度脂蛋白胆固醇水平的受试者比例。次要变量如下：对生活方式建议的依从性和对药物治疗的依从性；血脂谱和心血管风险水平的变化；心血管事件的发生情况；身体活动；食物消费；吸烟习惯；人体测量指标；血压；健康问题；降血脂药物的使用；社会人口统计学数据；对预防性建议的信念和期望；以及对综合策略的满意度。
如果该干预措施被证明有效，可以就将这种综合策略应用于高胆固醇血症患者发布一项建议。这是一种简单且相对便宜的干预措施。
ClinicalTrials.gov：NCT02314663。
