Hypercholesterolemia Clinical Trial
Official title:
Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients
BACKGROUND: Mediterraneans have traditionally a low cardiovascular risk, although emerging
lifestyles might change the trend. The aim of this study is to assess if
hypercholesterolemic patient involvement in the preventive decision with the help of a
decision aid has an impact on cardiovascular (CV) risk reduction superior to usual care.
METHOD: The design is a cluster randomised clinical trial. Participants are
hypercholesterolemic patients (>200 mg/dl or c-LDL>130) from four primary care teams of
Barcelona. Patients with previous CV events, age over 75 years or cognitive impairment are
excluded. It is expected to create two cohorts of 139 patients each one. The randomisation
is by doctor. Intervention group will receive information about their CV risk and the risk
and benefits of different preventive measures. They will have access to a decission aid that
will help them in the choice of the preventive measures.The material (printed and software)
is adapted to the Catalan Population using local CV risk tables and will meet the CREDIBLE
and DISCERN criteria. STUDY VARIABLES: Sociodemographic variables, CV risk factors,
subjective health (SF 12), decisional conflict, anxiety/depression, analytic controls,
treatment, treatment adherence, compliance and resources use. Basal evaluation and 3, 6, 12
month assessment. The study, financed by FIS, will begin the 01-07-2007.
RESULTS: The expected results are a higher reduction on the CV risk factors in the
intervention group versus regular care.
CONCLUSIONS Study will provide a tool to be used in Spanish and Catalan population.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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