Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients (PLEGATS)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients|
- Cardiovascular risk reduction [ Time Frame: one year ] [ Designated as safety issue: Yes ]Cardiovascular risk reduction measured throught REGICOR Spanish scale
- Life self-perceived quality [ Time Frame: one year ] [ Designated as safety issue: Yes ]Throught questionnaire SF-12
- Anxiety and depression [ Time Frame: one year ] [ Designated as safety issue: Yes ]Throught HADS scale
- Decision empowerment [ Time Frame: one year ] [ Designated as safety issue: Yes ]Otawa's decision scale
|Study Start Date:||July 2007|
|Study Completion Date:||March 2011|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
No Intervention: Control
Intervention arm using a share-decision tool for cardiovascular patients
|Behavioral: Share decision tool|
Please refer to this study by its ClinicalTrials.gov identifier: 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|