Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients (PLEGATS)
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|ClinicalTrials.gov Identifier: NCT01308866|
Recruitment Status : Completed
First Posted : March 4, 2011
Last Update Posted : March 4, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia Cardiovascular Risk||Behavioral: Share decision tool||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||298 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||March 2011|
No Intervention: Control
Intervention arm using a share-decision tool for cardiovascular patients
|Behavioral: Share decision tool|
- Cardiovascular risk reduction [ Time Frame: one year ]Cardiovascular risk reduction measured throught REGICOR Spanish scale
- Life self-perceived quality [ Time Frame: one year ]Throught questionnaire SF-12
- Anxiety and depression [ Time Frame: one year ]Throught HADS scale
- Decision empowerment [ Time Frame: one year ]Otawa's decision scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308866
|Barcelona, Spain, 08036|
|Cap El Castell|
|Castelldefels, Spain, 08860|
|Principal Investigator:||Joan Gene-Badia, MD, PhD||University of Barcelona, CAPSE, Health Policy Monitor|
|Study Chair:||Patricia Fernandez-Vandellos, RN, MpH||University of Barcelona|