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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01308866
Recruitment Status : Completed
First Posted : March 4, 2011
Last Update Posted : March 4, 2011
Preventive Services and Health Promotion Research Network
Information provided by:
Jordi Gol i Gurina Foundation

Brief Summary:

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
Allocation: Randomized
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

Arm Intervention/treatment
No Intervention: Control
Usual care
Experimental: Intervention
Intervention arm using a share-decision tool for cardiovascular patients
Behavioral: Share decision tool

Primary Outcome Measures :
  1. Cardiovascular risk reduction [ Time Frame: one year ]
    Cardiovascular risk reduction measured throught REGICOR Spanish scale

Secondary Outcome Measures :
  1. Life self-perceived quality [ Time Frame: one year ]
    Throught questionnaire SF-12

  2. Anxiety and depression [ Time Frame: one year ]
    Throught HADS scale

  3. Decision empowerment [ Time Frame: one year ]
    Otawa's decision scale

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01308866

Barcelona, Spain, 08036
Cap El Castell
Castelldefels, Spain, 08860
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Preventive Services and Health Promotion Research Network
Principal Investigator: Joan Gene-Badia, MD, PhD University of Barcelona, CAPSE, Health Policy Monitor
Study Chair: Patricia Fernandez-Vandellos, RN, MpH University of Barcelona

Responsible Party: Joan Gene Badia, University of Barcelona Identifier: NCT01308866     History of Changes
Other Study ID Numbers: PLEGATS
First Posted: March 4, 2011    Key Record Dates
Last Update Posted: March 4, 2011
Last Verified: March 2011

Keywords provided by Jordi Gol i Gurina Foundation:
cardiovascular diseases
patient education
primary health care
consumer participation
decision aids

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases