Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients

Conditions
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Hypercholesterolemia, Cardiovascular Risk

Intervention / Treatment
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* Behavioral: Share decision tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 14 and 75 years old having the inclusion criteria and consulting for cardiovascular risk diseases (CVD) in these centers. Patients who allow to participate in this study Exclusion Criteria: Patients with mental disorders. Secundary cardiovascular risk patients

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care | |
| Experimental: Intervention<br>Intervention arm using a share-decision tool for cardiovascular patients | Behavioral: Share decision tool<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risk reduction | Cardiovascular risk reduction measured throught REGICOR Spanish scale | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life self-perceived quality | Throught questionnaire SF-12 | one year | 
| Anxiety and depression | Throught HADS scale | one year | 
| Decision empowerment | Otawa's decision scale | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular diseases, patient education, primary health care, consumer participation, decision aids