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

Hypercholesterolemia Clinical Trial

— PLEGATS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308866
• Other study ID #: PLEGATS
• Status: Completed
• Phase: N/A
• First received: March 2, 2011
• Last updated: March 2, 2011
• Start date: July 2007
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: March 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiovascular Risk
• Hypercholesterolemia

Intervention

Behavioral:
• Share decision tool

Locations

Country	Name	City	State
Spain	Capse-Gesclínic	Barcelona
Spain	Cap El Castell	Castelldefels

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Preventive Services and Health Promotion Research Network

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular risk reduction	Cardiovascular risk reduction measured throught REGICOR Spanish scale	one year	Yes
Secondary	Life self-perceived quality	Throught questionnaire SF-12	one year	Yes
Secondary	Anxiety and depression	Throught HADS scale	one year	Yes
Secondary	Decision empowerment	Otawa's decision scale	one year	Yes