Hypercholesterolemia Clinical Trial
Official title:
Effectiveness of a Combined Strategy to Improve Therapeutic Compliance and Degree of Control Among Patients With Hypercholesterolaemia: a Randomised Clinical Trial
Background 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, 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.
Discussion 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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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