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

This study has been completed.
Sponsor:
Collaborator:
Preventive Services and Health Promotion Research Network
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01308866
First received: March 2, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

March 2, 2011
March 2, 2011
July 2007
September 2010   (final data collection date for primary outcome measure)
Cardiovascular risk reduction [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Cardiovascular risk reduction measured throught REGICOR Spanish scale
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients
Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Hypercholesterolemia
  • Cardiovascular Risk
Behavioral: Share decision tool
  • No Intervention: Control
    Usual care
  • Experimental: Intervention
    Intervention arm using a share-decision tool for cardiovascular patients
    Intervention: Behavioral: Share decision tool
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
298
March 2011
September 2010   (final data collection date for primary outcome measure)

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
Both
14 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01308866
PLEGATS
Yes
Joan Gene Badia, University of Barcelona
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
Jordi Gol i Gurina Foundation
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP