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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
  Purpose

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 Intervention
Hypercholesterolemia
Cardiovascular Risk
 Behavioral: Share decision tool

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Cardiovascular risk reduction [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Cardiovascular risk reduction measured throught REGICOR Spanish scale


Secondary Outcome Measures:
  • 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


Enrollment: 298
Study Start Date: July 2007
Study Completion Date: March 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Usual care
Experimental: Intervention
Intervention arm using a share-decision tool for cardiovascular patients
 Behavioral: Share decision tool

  Eligibility

Ages Eligible for Study:   14 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308866

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

No publications provided

Responsible Party: Joan Gene Badia, University of Barcelona
ClinicalTrials.gov Identifier: NCT01308866     History of Changes
Other Study ID Numbers: PLEGATS
Study First Received: March 2, 2011
Last Updated: March 2, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

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

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013