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| Name | Class |
|---|---|
| Preventive Services and Health Promotion Research Network | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Usual care | |
| Intervention | Experimental | Intervention arm using a share-decision tool for cardiovascular patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Share decision tool | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular risk reduction | Cardiovascular risk reduction measured throught REGICOR Spanish scale | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Life self-perceived quality | Throught questionnaire SF-12 | one year |
| Anxiety and depression | Throught HADS scale | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan Gene-Badia, MD, PhD | University of Barcelona, CAPSE, Health Policy Monitor | Principal Investigator |
| Patricia Fernandez-Vandellos, RN, MpH | University of Barcelona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capse-GesclĂnic | Barcelona | Barcelona | 08036 | Spain | ||
| Cap El Castell |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Decision empowerment | Otawa's decision scale | one year |
| Castelldefels |
| 08860 |
| Spain |
| D009750 |
| Nutritional and Metabolic Diseases |