Abstract
BackgroundIn 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/DesignA 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.DiscussionShould 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.Trial registrationClinicalTrials.gov: NCT02314663.
Highlights
In subjects with hypercholesterolaemia, cholesterol values remain above guideline levels
Should this intervention prove effective, a recommendation could be issued on the application of this combined strategy to subjects with hypercholesterolaemia
Hypercholesterolaemia is one of the main cardiovascular disease risk factors (CDRFs) and, according to different studies undertaken in Spain, its prevalence in terms of total plasma cholesterol concentrations of over 250 mg/dl, extends to 20%-23% of the adult population [1,2]
Summary
The prevention and treatment of dyslipidaemia should take the remaining CDRFs into account, with its management being based on the calculation of cardiovascular risk. Despite guidelines and new hypolipidaemic agents, the results of different studies show that cholesterol values remain above guideline targets [8]. Studies, such as HISPALIPID [9] and PREVENCAT [10], have revealed poor control of subjects with dyslipidaemia, with the designated targets being attained in approximately 32% of cases. The EUROASPIRE II study reported that 64% of patients with coronary disease took hypolipidaemic agents, and that approximately 53% failed to display adequate therapeutic control [8]. Among the possible causes of this situation are factors linked to hypolipidaemic agents, adherence to prescribed treatment and physician-led prescription strategy
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